Affordable HIV drugs are finally reaching
people with Aids in Africa and beyond.
But what is preventing the trickle from
becoming a torrent, asks Bob Huff
Against all odds, treatment for HIV is expanding in Africa and elsewhere in
the developing world. Brazil led the way in the late 90s by producing affordable
generic anti-retroviral (ARV) drugs in its own factories, available free to
all 140,000 HIV positive citizens. By daring to break the monopoly of the
multinational patent holder companies, the country dropped the average cost
of a year’s therapy from $10,000 to less than $600.
India’s historically flexible patent laws allowed its generic drug industry
to export affordable drugs to Africa, where non-governmental treatment programmes,
run by organizations like Médecines San Frontières, soon proved
that providing HIV treatment in severely resource-limited settings was feasible.
Competition among the Indian generic manufacturers quickly pushed the average
price of ARV therapy to as little as $140 per year.
The backlash begins
When Brazil first acted, drug companies mounted an all-out campaign
to defeat the affordable drugs movement. This included a whispering campaign
to reinforce the conventional wisdom that offering treatment in Africa was
a fantasy. Experts pointed to gaps in African infrastructure and cited lack
of trained staff, clean water (and more bizarrely, lack of wrist watches)
as insurmountable barriers. Many observations were valid but the naysayers
implied treatment was futile unless every underlying problem could first be
solved. A few groups worked hard to show that treating Africans with affordable
drugs was possible with minimal infrastructure, helping to convince northern
governments and funders to undertake the World Health Organisation’s
‘3 by 5’ target of treating three million infected people in low-
and middle-income countries by 2005. This could not have happened without
generic drugs.
Patent wars
As the propaganda war slipped away from them, the pharmaceuticals turned to
lawsuits before surrendering and offering branded drugs and no-profit prices
through charity programmes. It is likely they gave ground because the only
battlefield that mattered was in the domain of international trade law, where
they enjoyed overwhelming superiority. Big drug companies obstructed affordable
generics, not because they feared the loss of markets but because they feared
losing their patent monopolies – their intellectual property. They were
terrified of seeing the example spread elsewhere. Compulsory licensing in
Brazil; generic production in India; the threat of re-importation of low cost
or charity drugs from Africa to the European markets, were all portents of
doom. What if US consumers began demanding affordable medicines? The principle
of ownership, everywhere, with no limits on monopoly control, has been the
real battle prize.
Progress – of sorts
Funding from the new Global Fund for Aids, Tuberculosis and Malaria and other
sources encouraged governments to expand the scope of their health programmes.
The US President’s Emergency Plan for Aids Relief (PEPFAR) has funded
treatments largely based on brand name drugs from originator companies. Other
treatment programmes in Africa, funded by charities, religious groups and
businesses, continue to grow, using donated drugs from the multinational companies,
heavily discounted branded drugs and purchased generics. The availability
of treatment in Africa in 2005 has evolved beyond what many thought possible
just five years ago, yet it still falls far short of what is needed.
Despite progress, the overall picture of HIV treatment in the developing world
is spotty, with only about 12 per cent of the eight million people who need
ARVs receiving them at the end of 2004. The ‘3 by 5’ plan is likely
to wind up treating about 1.2 million. Although credible reports suggest the
WHO expect to hit the target by the middle of 2006. Disbursements from the
Global Fund are lagging. One bright spot is the fast-growing PEPFAR programme,
which is ahead of schedule in bringing 470,000 people under care by June of
2006. Yet this too addresses only a fraction of the need. Although low-cost
generic drugs made these gains possible, it is becoming increasingly clear
that the facilities, staff, equipment and supplies needed to assure the quality
and sustainability of these fledgling treatment efforts is not available at
a similar discount. Despite the good start, millions living with HIV remain
at risk unless sustainable
solutions to these problems are found.
Hobson’s choice
The most common generic ARV
regimens used in the developing world are based on nevirapine, supported by
lamivudine plus d4T or AZT. Although the decision to roll out these drugs
was driven by their low cost and easy availability in generic form, the regimens
are effective, even if problematic for many. Nevirapine in particular can
be tricky. Close monitoring is recommended during the first months to avoid
liver
toxicity, especially in women. Efavirenz might be an alternative, but so far
the generic price for efavirenz is no better than the price from the patent
holder. Nevirapine is also not very forgiving of interrupted or intermittent
dosing. When a nevirapine-based regimen fails due to resistance, there are
few good choices in the developing world. Ideally a switch would be made to
a protease inhibitor such as Kaletra, but it requires refrigeration, which
can’t be guaranteed in many settings. The drug is also far more
expensive than nevirapine and there is no generic version available.
Tenofovir is an attractive replacement for stavudine or AZT because of its
potency and minimal side effects. But it is not available from India’s
generic makers and may never be, due to recent changes in patent law. Tenofovir
is available as second-line therapy in some PEPFAR and other programmes, supplied
under Gilead’s no-profit programme for countries that can’t afford
it otherwise. Currently, the no-profit price of Gilead’s tenofovir is
about $25 a month, which compares to a price of about $3.30 for generic d4T
from India. But with fresh reports about d4T-associated facial wasting in
Thailand, and peripheral neuropathy in Kenya, when does the cost of the cheapest
drugs become too great?
Quality counts
India’s huge generic drug industry makes medicines for the world,
including the US, and many of the Indian ARV makers use factories inspected
by the US Food and Drug Administration (FDA). The WHO also maintains a list
of ARV drugs vetted for quality and consistency by its own drug regulatory
experts. Many large government and NGO purchasers rely on this ‘pre-qualification’
list when deciding which drugs to buy. In 2004 several WHO-certified
generics were removed from the pre-qualification list, which sent ripples
of uncertainty through the patient community. The drugs were de-listed after
WHO found irregularities in ‘bioequivalence testing’. These are
clinical studies that show if the generic version of a drug delivers the same
amount of medicine to the blood that the brand name drug, therefore proving
its effectiveness. In this case a research contractor hired by one of the
drug companies cut corners when performing the tests. The studies have been
repeated using a different contractor and re-listing is expected soon.
The Barriers to success
The PEPFAR programme has additional standards for the drugs it will purchase
– it is only interested in drugs approved by the US FDA. However, many
critics see FDA involvement as a redundant barrier erected to protect the
US drug industry – the head of the Bush administration’s international
Aids effort is a former pharmaceutical company executive. Still, the US government
has said generic drugs will be acceptable to PEPFAR once they have been approved
by the FDA. Several Indian generic drugs will soon clear this hurdle and critics
will watch to see if they join the brand name drugs dispensed by PEPFAR doctors
in Africa and elsewhere. Although there are still barriers to reaching the
lowest possible price for first-line generic ARVs, it’s not clear that
even halving drug costs will increase the number of people treated beyond
a
certain point. Low cost generics primed the pump and made Aids treatment in
Africa conceivable, but even free drugs won’t make it into bodies without
the supporting infrastructure.
‘Two-tier treatment’
We may be seeing the emergence of two tiers of treatment in Africa: PEPFAR,
with its newer, less toxic drugs, US trained staff and full service monitoring;
and the generic-based programmes that use less monitoring and older, cheaper
drugs with more side effects. Both are keeping people alive, but one is a
rich programme and the other is struggling with limited means. If PEPFAR leaps
ahead as the largest treatment provider in Africa, the benefits may trickle
down as staff are trained and know-how is transferred to more and more people.
But critics charge that PEPFAR is already sucking the life out of some government
programmes by luring trained staff away with higher pay. Many believe only
broad-based, government-led programmes that strive to reach everyone in a
country are likely to sustain their impact in the long run.
Optimism the only option
There is reason to be optimistic about the prospects for treating HIV in Africa.
Momentum is building, but now the course is shifting to difficult terrain.
If there is the will to purchase and pay for drugs, then it is likely they
will continue to be supplied by someone, somewhere. But who is going to transport,
store, reorder and dispense them? Who will pay for training more doctors,
nurses and peer counsellors? There is a need to educate, simplify and reduce
the cost of diagnostics; to settle on new treatment guidelines; find better
second-line, third-line and less toxic regimens. There is a need to tackle
corruption and build political will and lift the crushing burden of debt.
The cost of drugs has receded as the main challenge but it threatens to re-emerge
if the supply is cut off or if there is a spike in prices due to world economic
events. Or will donor fatigue slowly strangle the life from the effort? Global
Fund donors are already backing away from their commitments. A fragile government’s
health plans can be disrupted overnight by disaster or war. The PEPFAR dollars
could be cut by the whim of Congress, and there is fear that the top notch
infrastructure it has erected would collapse faster than more modest, independent
programmes. But no matter why or how, when the money stops or the drug shipment
does not arrive, the impact will be slow devastation and a slide back into
despair.
• Bob Huff is the editor of GMHC Treatment Issues, New York. This article
is reprinted from it with kind permission.
