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Past Issues
Volume 16, number 7
July/August 2002
Contents
Recuerdo de Barcelona
A random walk through a forest of data
Let Pfizer be Pfizer
Hank bets the pharm in Barcelona
AIDS 2002
A personal perspective
Taking Care of Our Own
Heineken steps up
Short Course
Notes on drugs in development
The World Turns
Why is progress so painfully slow?
Three Million/Three Years
Gregg Gonsalves looks for leadership
The State of AIDS at the
Barcelona Conference
By Bob Huff
Inside the biennial International HIV/AIDS Conference there is
a forest of speakers and slides on everything from the plight of
women in Pune to the ambiguous status of Tat in vitro. This comprehensive
conference on the state of AIDS is organized into seven tracks,
A through G. The theme of each track is represented in a high-profile
plenary speech or two but elaborated in multiple simultaneous slide
talks and thousands of individual poster presentations. It's impossible
to see everything; with up to ten oral sessions running at once,
it's difficult to catch ten percent of what is presented.
Track A is the domain of basic scientific research into the virus
and its effects on the immune system. Track B covers the clinical
manifestations of HIV disease and the impact of drugs and diagnostics.
Track C portrays what we know from epidemiology, where the spread
of HIV is tracked into new and familiar populations. Track D considers
the range of prevention efforts addressing people both with and
without HIV. Track E is a grab bag of social science investigations
into issues of underlying social and cultural risk factors for HIV
infection, including stigma, and the impact of the disease on families
and communities. Tracks F and G focus on efforts to implement prevention,
care, treatment and support programs to reduce the impact of AIDS.
Track F sticks to the details of undertaking those efforts while
Track G explores the political implications and deals with policy
and advocacy issues.
The tracks delineate boundaries between specialized bodies of knowledge,
but they're really all related. When you select one key from a key
chain and hold it up, all the others dangle below. Grasp any fact
about HIV/AIDS and you can trace its relationships to a thousand
other facts and problems. Drop into a session on Bangladeshi attitudes
about marriage and you're only a few conceptual steps from the legal
status of widows, the economy of sex work, microbicides and mucosal
immunity.
With the number of HIV infections threatening to reach 100 million
within five years, the tone of this conference was wary but optimistic.
Many attendees noted the emerging consensus to move forward with
a dramatic scaling-up of prevention efforts and plans to extend
care and treatment to millions of people who have been left behind.
A goal announced by the World Health Organization (WHO) to deliver
antiretroviral therapy (ART) to three million people in the developing
world within the next three years was taken as a kind of "moonshot"
challenge. The task will require drawing deeply on the knowledge
accumulated by workers in every track of HIV/AIDS studies. But although
the commitment is strong, attendees looking for lessons learned
by trailblazers found slight guidance.
At the closing session of the conference, in the hours before Nelson
Mandela and Bill Clinton spoke, a track-by-track summary of the
week's events was presented by a series of distinguished rapporteurs.
All of the presentations were excellent (I wish they were included
among the webcasts available on the conference site: www.aids2002.com)
but one was notable. The final speaker, Terje Anderson, of the U.S.
National Association of People with AIDS (NAPWA) reviewed the range
of policy and advocacy issues discussed in Track G and focused on
persisting inequities. "Without question," Anderson said,
"we found here in the sessions and speeches a stronger awareness
than ever before that marginalization and stigma continue to shape
and define this epidemic." While courts of law have been successfully
used to expand access to medications and remove barriers to treatment,
he continued, bad law also punishes efforts to teach rational prevention
messages and fails to protect the autonomy of people with HIV. "The
AIDS movement has become adept at operating within a human rights
framework, and using that framework to advance access to treatment,
prevention, and ethical research standards. Yet that framework is
far from universal."
Anderson also cited the critical leadership role that people living
with HIV play in the creation of policy and legislation but warned
that, "in order to be real, the meaningful involvement of people
living with HIV/AIDS requires real action and commitment, not just
ideological lip service." He specifically questioned whether
the consensus to treat three million people within three years had
really involved input from those it affects most: "How does
three million relate to the number of people who need ART. Did anyone
ask those who will not receive treatment if they accept this goal
as 'consensus'?"
Anderson stressed that the lessons from this meeting must be taken
home and implemented: "... this conference clearly showed that,
more than ever before, this fight is being fought, and must be fought,
on a political plane. That it requires engaged political leadership
and that it is our responsibility to engage those leaders when they
don't seem to be paying attention the way they must. Yet it remains
unclear if scientists, doctors, people living with HIV/AIDS (PLWHA),
non-governmental organizations (NGOs), service providers, and other
relevant players are truly willing to take the risks associated
with entering the political arena. It may be safe to give advocacy
speeches and blow whistles among like-minded people at an AIDS conference,
but how many are willing to do the same when it could mean loss
of government funding, loss of access to decision makers, unemployment,
social isolation, or the personal experience of discrimination and
stigma?"
What follows is a random walk through a handful of oral sessions
at the conference, track by track, from political interventions
to protein interactions.
Track F - Interventions
The use of single dose nevirapine to prevent mother to child transmission
(MTCT) of HIV has been proven safe, effective and appropriate in
situations where minimal pre-natal care is available. But programs
have encountered reluctance on the part of some women to accept
voluntary counseling and testing (VCT) without the consent of their
husbands. An antenatal VCT program in Lusaka, Zambia encouraged
women to bring their spouses for testing, but there was little response.
Active strategies were designed to raise awareness among men in
the community about HIV and VCT and engage husbands in a discussion
about HIV testing. Among these:
- Outreach workers actively recruited spouses in their homes.
- Educational outreach campaigns and public forums with community
leaders were launched.
- Couples were invited to receive counseling.
- Saturday clinic hours were established.
- People with publicly disclosed HIV were involved.
- Support groups for HIV-positive people were established.
The result was a dramatic increase in the number of couples receiving
VCT. Uptake of testing among men attending counseling was 92%; HIV
prevalence was 34%. The authors conclude that "Couples counseling
may help facilitate better uptake of interventions to prevent transmission
to children and is more likely to be effective to support primary
prevention of HIV transmission." (Shutes E, MoOrF1032)
Track E - Social sciences
An analysis of interviews with men and women living in the slums
of Chennai revealed the depth with which violence to women is embedded
in the culture. Most respondents held that men typically beat their
wives as a normal part of married life. "Women described being
slapped, kicked, having their head hit against the floor and being
burned with lit cigarettes; some were struck with objects such as
ladles or stones. Slapping or hitting the face was the most frequent
type of violence and physical consequences such as recurring headaches
and blurred vision were noted." But although wife beating was
accepted as the social norm, there was discordance between men and
women as to the acceptable limits of the violence. The authors conclude
that in this culture, if a woman wishes to minimize violence, her
ability "to insist on monogamy, negotiate condom use or refuse
sex is limited." Therefore, within this context where violence
is a gender norm, prevention messages that target men are likely
to be most productive. (V.F. Go, Johns Hopkins; WeOrE1284)
Globally, 30 percent of people infected with HIV are between ages
15 and 24, and over half of new infections occur in this group.
Young women are particularly at risk because they lack economic
resources of their own and often become dependent on men. Some prevention
programs aimed at youth tend to treat young people as a problem
and ignore conditions that leave them vulnerable. A program in Nigeria
tried an integrated approach to reach adolescent girls and young
women and address the underlying issues that make them more vulnerable
to HIV. The integrated approach views youth as a resource and seeks
to make them participants rather than audience members. A training
manual was designed that combined sexuality education and entrepreneurial
education. The training sessions demanded about four hours a week
and ran for about six months. When trainees completed the course
they became qualified as peer counselors in HIV/AIDS and reproductive
health.
Girls who wrote business plans were also given vocational training
in fields such as hairdressing, fashion design and tie-dye, and
offered microfinancing (about $150) to begin small businesses. This
program in Oyo state sought to train 1000 girls; 303 young women
completed training in reproductive health and entrepreneurial skills.
Of these, 73 women wrote business plans and 34 were supported with
financing. As peer educators, the girls subsequently provided sexual
health counseling to about 65,000 young people. The program reported
that when young people were given the skills and backing to start
their own business they gained in self-esteem and independence.
Girls with enhanced self worth were better able to make informed
decisions and contribute to their community's development. "Economic
independence helped to reduce vulnerability to sexually transmitted
diseases (STDs) including HIV/AIDS" (Olatidoye F, MoOrE1026)
Track D - Prevention
A randomized trial was conducted in STD clinics in three cities
in the United States to compare conventional HIV testing employing
two counseling sessions one to two weeks apart, to rapid HIV testing
employing two sessions delivered on the same day. The two outcomes
of interest were the number of test results received by clients
and the incidence of STDs during the subsequent year. The investigators
enrolled 3293 individuals who were interviewed and screened for
chlamydia, gonorrhea, and trichomoniasis at baseline and again every
three months for one year. Participants were tested for HIV and
syphilis at baseline and again at 12 months. Roughly half of the
participants were female; ages ranged from 15 to 39 years.
Nearly all (>95%) participants given a rapid HIV test received
their results, while only 68% of those who were given a conventional
test returned to learn the outcome. However, significantly more
people who received the rapid test were diagnosed with a new STD
at six months than those who had the conventional test with two
counseling sessions (22% versus 12.6%, p= .04). However, by 12 months
this gap had narrowed and was no longer statistically significant
(18.8% versus 16.9%, p= .14).
Several rapid HIV tests are moving towards FDA approval in the
U.S. pressed by the recognized need to reach significant numbers
of people who fail to return for conventional test results. This
is an important study because it assesses whether good-quality risk-reduction
counseling given in a single clinic visit can be as effective at
preventing STDs and reducing risky behavior as conventional counseling
delivered over two successive clinic visits. (Metcalf CA, MoOrD1019)
A study in Nairobi, Kenya looked at how people typically sought
care for STDs in that city and what kind of advice and treatment
they received. A previous program had trained 600 qualified providers
in syndromic diagnosis and treatment of STDs. Surveys in homes,
streets and markets assessed how frequent STDs were and recorded
how they were treated and by whom. The providers were then visited
to establish whether they had received training or not.
About 15% of the adults contacted in the survey reported having
an STD in the past year. "Of these, 25% did nothing; 10% went
directly to a medicine shop; and 65% sought treatment. Of those
who sought treatment, 44% went to a government clinic; 39% to an
untrained private provider, and only 17% to a trained private provider."
Neighborhood medicine shops are a frequent source of advice and
treatment for STDS. As part of the study, a number of these shops
were visited by young men and women who acted as undercover "mystery
shoppers." Half of them described symptoms of common STDs and
half presented a prescription to be filled. Of the male mystery
shoppers who described symptoms of syphilis, only 1 in 18 were given
the correct medication and 5 of 27 males describing gonorrhea were
correctly treated. Of females, only 1 in 11 of those presenting
syphilis and 1 of 20 describing gonorrhea were correctly treated.
In larger medicine shops, only 63% of prescriptions were filled
due to unavailability of the drugs.
The authors conclude that, "Training 600 private providers
was a good start, but to improve coverage either these trained providers
must be more actively marketed to STD patients, or training must
be extended to unqualified providers. Medicine shop staff are really
bad at diagnosing STDs. They should be trained to refer." (Nkatha
C, TuOrD1154)
Track C - Epidemiology
At the Durban conference in 2000, there was much evidence that circumcision,
especially if performed early in life, is a protective factor for
acquiring HIV. The biological rationale is that the mucosa of the
glans penis in circumcised men becomes keratinized and resistant
to irritation and infections. But previous studies compared men
from different communities with possibly different sexual behaviors.
For example, low rates of HIV among North African Islamic men may
be attributed to circumcision, the practice of washing before and
after sex, or the practice of keeping multiple partners within closed
sexual networks. These confounding factors make conclusions uncertain.
To minimize the effect of cross-cultural practices, Kawango Agot
and colleagues performed a study to assess the prevalence of HIV
among culturally homogenous circumcised and uncircumcised men in
the Luo ethnic community in rural Kenya. The men selected were members
of an African instituted church congregation, were all sexually
active, and ranged in age from 18 to 59. Of 1217 men contacted,
845 agreed to be tested for HIV and have their circumcision status
confirmed.
The seroprevalence of HIV-1 was 30.2% among 447 uncircumcised men
and 19.8% among 398 circumcised men. Uncircumcised men (who did
not use condoms) were at greater risk for having HIV independently
of other demographic or sexual behavioral factors.
This cross sectional study supports the biological rationale for
the protective effect of circumcision. A randomized, controlled,
treatment trial comparing circumcision plus risk reduction counseling
to counseling alone is underway. (Agot K, ThOrC1486)
French researchers examined a large cohort of HIV seroconvertors
to see if the rate of progression to AIDS differed between men and
women. The study considered both the "natural course"
of infection in 424 individuals (94 women, 22%) observed for a median
of 75 months before the advent of HAART in 1996, and in 531 individuals
(167 women, 31%) who started HAART while in the cohort and had been
followed for a median of 37 months. The effects of gender were evaluated
in the pre-HAART group by time since infection to clinical AIDS,
to CD4 count under 200, and to death. The post-HAART group was tracked
for changes in CD4 count and viral load since starting HAART and
for time to an AIDS defining event.
Men and women enrolling in the pre-HAART group were similar as
to age (28 vs. 31 years), CD4 count (569 vs. 688) and viral load
(4.1 vs. 3.7 log). "Progression to AIDS was lower in women
(RR=0.4, p<0.01). This benefit persisted after adjustment for
age, baseline CD4 and VL (RR=0.5, p<0.04)."
At the time of starting therapy in the post-HAART group, men and
women had nearly identical CD4 counts (247 vs. 246) and viral load
(4.2 vs. 4.1 log). After 12 months on HAART, men and women experienced
similar increases in CD4 count (86 versus 102) and decreases in
VL (1.2 vs. 0.9 log). "Adjustment for age, CD4 and VL at HAART
initiation, and prior use of ART did not modify this result."
The authors did not find evidence that women with similar viral
load to men progress to AIDS at a more rapid rate in either the
natural course of disease or after initiating HAART. (Hubert JB,
ThOrC1448)
Track B - Clinical science
One vexing problem facing efforts to scale up treatment in the developing
world has been the lack of basic infrastructure such as transportation
and refrigeration. In particular, diagnostic assays have been designed
and validated under conditions where rapid and safe transport to
laboratories is common. One proposed solution to the problem of
safely transporting tubes of blood is to collect samples as dried
blood spots on filter paper.
A Thai group performed a validation test of dried blood spots by
collecting whole blood, plasma and spots and processing them in
parallel. Samples were tested for both HIV RNA and DNA detection
and for HIV RNA viral load. The investigators also collected spots
and stored them at a range of temperatures for periods up to one
year, then tested them for reproducibility of viral load.
In the series of stored samples, dried blood spot viral load results
were reproducible within 0.5 log at copy numbers above 10,000 out
to three months. The other tests were qualitatively comparable to
the reference tests. The authors conclude that dried blood spots
are reliable and stable for HIV detection and viral load analysis.
(Chaowanachan T, WeOrB1339)
A latebreaker report on ACTG 384 may be the stand out of the conference.
This was a complicated, multifactorial trial conducted by the U.S.
AIDS Clinical Trials Group. In a nutshell, the study convincingly
shows that beginning therapy with efavirenz/AZT/3TC is better than
starting with nelfinavir/ddI/d4T. These assumptions were already
reflected in the British HIV Guidelines but have been slow to be
embraced in the U.S. This study may have a big impact on the guidelines
for selecting simplified regimens for use in low resource settings.
Interestingly, seven years after the protease inhibitor revolution,
the best first line therapy has turned out to be a one-target strategy,
with PIs now a second line choice.
Track A - Basic science
This track offered a full program of talks and posters, yet little
that was memorable. Most scientists now reserve their important
presentations for the annual Retrovirus conference held in the U.S.
each winter. The International AIDS Society (IAS) last year began
another biennial conference, held in the years between the large
International Conferences, that they hope will develop into an important
basic science meeting. So far the Retrovirus conference is safe
on its perch, but the new IAS meeting has the potential to become
an important catalyst for accelerating the scale-up of treatment
and care projects.
On the immunology front, one development with important implications
is the growing body of evidence that HIV can mutate to escape from
immune control in a way that is analogous to escape from drug pressure.
At this meeting, more people got their first look at evidence that
the virus can escape from suppressive control by cytotoxic lymphocytes
(CTL). Bruce Walker reported on an individual who had successfully
been able to control replication of his virus without treatment
then experienced a sudden surge in viral load. Sequence analysis
of the individual's virus revealed that he had been infected with
a new viral strain that his immune system no longer recognized.
This may be the first documented case of super-infection; if it
is a common phenomenon, this news does not bode well for current
vaccine strategies that try to elicit suppression by CTL.
In another report of super-infection, Stephanie Jost of the University
of Geneva described the case of a male participant in a European
clinical trial with documented subtype AE HIV who experienced a
viral load spike during a planned treatment interruption. Sequence
analysis of the virus dominant at the time of the spike was documented
as subtype B. Co-infection was ruled out by failing to find any
evidence of subtype B virus in earlier stored samples. This particular
strain of subtype B virus is associated with strains found in Brazil.
Three weeks before the patient's viremic episode, he had vacationed
in Brazil where he reported having several unprotected sexual contacts.
(S. Jost ThOrA1381)
There was data on viral escape from host cytotoxic lymphocytes
(CTL) in monkeys presented by David O'Conner from the Wisconsin
Regional Primate Center. This group showed that during acute infection,
epitopes in the SIV genome that tend to stimulate the first wave
of strong CTL immune responses were also the first to mutate in
the functional virus. These mutations ultimately allow SIV to escape
the body's alien detection and removal system. CTL responses that
arise later, during the chronic phase, are less likely to escape
but are also less able to control infection. He also reported that
acute phase mutations occurred throughout the viral genome, involving
more than just the few key epitopes. The group also speculates that
the rapid pace of mutation observed during acute phase may be responsible
for generating the tremendous diversity of viral variants seen circulating
in populations. (O'Conner D, TuOrA1179)
For diehard fans of virology, a session on the role of the "accessory"
proteins was notable. Warner Greene from the Gladstone Institute
in San Francisco took a shot at the session's title. "There
are no 'accessory' proteins," he said, "they are all essential."
He also commented that with integrase inhibitors on the horizon,
we have run out of viral enzymes as therapeutic targets and are
now beginning to explore interfering with protein-protein interactions.
He cited the entry inhibitor T-20 as the first example of this kind
of therapeutic.
Tat is an essential accessory protein that was recognized early
on as giving a big boost to the ability of HIV to replicate. When
an infected cell starts to make new copies of HIV, Tat is one of
the first proteins summoned. Without Tat, the cell's genetic machinery
can transcribe copies of HIV, but it is a slow process. Once Tat
is on the scene, the machinery kicks into high gear, transcribing
the HIV genes thousands of times faster than before. But it seems
that Tat can't help being helpful and several new functions of Tat
are now being recognized.
Mark Wainberg elaborated news about Tat that he presented at the
Retrovirus Conference earlier this year. He suggests that Tat may
have a dual nature depending where it finds itself during the viral
lifecycle. At a later stage, when new virions are being assembled
and packaged, TAT may help suppress the reverse transcriptase protein
to keep it from transcribing the viral RNA at an inappropriate time.
This ability to suppress DNA elongation seems to be located in the
second exon of the tat gene (see below). But two other functions
of Tat (associated with the first exon) actually help reverse transcription
take place by facilitating the placement of new nucleotides on the
growing DNA chain. So depending on the situation, Tat can either
help or suppress RT activity. Interestingly, the helping functions
are also performed by a completely different protein, so Tat seems
to serve as a backup. This dual nature illustrates the complexity
of protein interactions in the HIV life cycle and suggests how much
more basic research needs to be done. (Wainberg M, WeOrA1259)
Kuan-The Jeang zeroed in on some quirky observations about the
Tat protein. There are two coding regions on the tat gene of HIV
and SIV; together they code for the tat gene product, which is necessary
to make a fully virulent virion. But Jeang presented data suggesting
that a tat gene that only expresses the first exon but not the second
is less stable, hence less virulent and maybe associated with milder
disease. (Exons are the regions of a gene that directly code for
a protein; expression is the process of turning of an exon into
a protein.) While this has been observed in test tube experiments
with cells, such data is never as compelling as data from living
creatures. Jeang crafted a modified SIV (monkey virus) that only
expressed the first exon of tat. The virus was engineered with a
stop codon placed just before the second exon begins. He then infected
four rhesus monkeys with this artificial virus (tat1ex) and two
monkeys with the unmodified two-exon tat virus (tat2ex). The monkeys
that received the two-exon virus quickly developed high viral loads
and had a progressive course of disease. But the four monkeys infected
with one-exon virus maintained low or undetectable viral loads during
the first few months after infection. Eventually, two of these monkeys
took a turn for the worse. Sequencing the tat region of their viruses
revealed that the stop codon preventing the second exon from being
expressed had mutated to allow the full Tat to be made. The evolutionary
switch of this one signal allowed normal disease progression to
occur.
Monkey experiments are interesting but far less convincing than
studies in people. Of course, this study would be impossible to
perform in humans. But remarkably, Jeang discovered "an experiment
in nature" that supported his observations in the monkeys.
It seems that, between 1985 and 1990, three laboratory workers were
accidentally infected with a special investigational strain of HIV
(HXB2) that had a blocked second exon in tat. Here was an experiment
that could never be carried out deliberately. Jeang reviewed the
medical histories of the three individuals - all still living -
and sequenced their virus from stored samples. Two of the lab workers
have had a rather uneventful course of disease with only modest
T-cell declines after all these years. The third individual has
had a more variable history with periods of stability and other
periods of high viremia and T-cell loss. The gene sequence data
showed that his periods of disease progression were correlated with
a mutation at the stop codon in the tat gene that unblocked the
second exon. The sequencing data showed that the other two individuals
never experienced an unblocked second exon.
This is a small, but convincing demonstration of the theory that
a blocked second exon of the tat gene is associated with a milder
course of disease. It also raises the question of whether a therapy
that restricted this gene or its product could lessen the impact
of an existing infection. (Jeang KT, WeOrA1256)
Philosophy
in the Boardroom: Hank Takes Barcelona By Bob
Huff
What does it mean when the least healthy-looking person in a room
full of AIDS luminaries is the U.S. Secretary of Health? At a dinner
party given by Pfizer Chairman and CEO, Henry (call me "Hank")
McKinnell at Antoni Gaudi's most elaborate private residence in
Barcelona, it meant delicious fruit soup and the Secretary's jetlagged
countenance on a dozen flat screen TVs throughout the hall. Thrice
invoking the "insidious scourge" - a phrase better left
to the mujahadin of a different war -HHS Secretary Tommy Thompson
urged us to bring our cudgels to the battle. The protesters who
drowned him out the next day during his talk at the conference center
don't know what they missed.
Cudgels to the side, the real reason we had been collected for
this typically late-night Spanish feast was to hear Hank throw down
a gauntlet - or at least his keenly felt position paper - on Pfizer's
proper role in society in general and in the war against HIV/AIDS
in particular. His message, summed up, is: "Let Pfizer be Pfizer."
By this Hank means that a research-based pharmaceutical maker will
do best when it's free to discover and develop new drugs that benefit
patients, and then sell those drugs at rates that generate sufficient
profit to feed its investors and keep the research juggernaut rolling
through good times and bad. For this audience, he meant that drug
sales in the rich northern countries must produce enough income
to subsidize access to drugs in parts of the world less able to
pay. In the case of AIDS drugs, the rest of the world happens to
be where the greatest need resides. You can't have it all and expect
cheap drugs too, says Hank.
This message was aimed at a number of audiences, including advocates
for affordable access to essential medications for TB, malaria and
HIV/AIDS, although many players have already accepted this logic.
UNAIDS, in its call for a "new deal" with the pharmaceutical
industry, has said, "high-income countries need to continue
to support the ... financing systems that allow for investment to
be recouped for research and development." But that night,
the key target may have been Hank's friend, Secretary Thompson,
who, as the chief of the Department of Health and Human Services
and an influential member of the Bush administration, stood as a
representative of the largest buyer of pharmaceutical products in
the world: government. When Hank says the rich countries need to
acknowledge their role in paying the freight for the continued flow
of drugs to the poor countries, he was pointing the finger at efforts
by government to reign in drug costs and beat down prices through
coop buying, preferred list schemes and threats of patent reform.
One pending strategy, importation of drugs from Canada, is awaiting
a green light from Secretary Thompson. These efforts, Hank implied,
need to stop. Now.
Pfizer spends $100 million a week on research, said Hank. This
shocking number amounts to about $5 billion a year, a figure that
roughly tallies with Pfizer's financial statements. After the close
of the conference, it was revealed that Pfizer plans to merge with
another research giant, Pharmacia, Inc., producing a marketing powerhouse
with an R&D budget one third the size of the National Institutes
of Health. As a former chair of the U.S. trade organization, Pharmaceutical
Research and Manufacturers of America (PhRMA), Hank is no stranger
to shocking figures that dramatize the risks of drug making. On
the first day of the Barcelona conference, two stories dominated
the international CNN report. The first story broadcast the PhRMA
mantra that developing a single new drug costs $800 million on average.
This prefaced the core message disseminated from the conference
that day, one that curiously echoed Hank's: industry can't be expected
to sustain a flow of reduced price drugs to the developing world
if profits are not generated elsewhere.
Interestingly, the other top story on CNN was a report that pharmaceutical
giant Merck had overstated revenues by $14 billion during the past
few years by claiming the co-pay dollars pharmacists collect from
consumers. Later in the week, Bristol Myers Squibb was also revealed
to be under investigation for inflating earnings. One wonders how
the industry can claim its profits are under attack if those profits
aren't even real.
Hank's world is changing and although he and his company seem to
be out front in their willingness to listen, accommodate and adapt,
some of his arguments seem stale and rooted in PhRMA rhetoric. The
pharmaceutical industry has historically been a good performer for
investors, returning a better reward than such hardware-intensive
industries as aircraft manufacturing - although not so much as the
high-flying Internet stocks did during the late nineties. During
those go-go years, competition in the capital markets drove the
need for more prosaic businesses to maximize profit at all costs.
Companies like Enron and WorldCom chose to borrow against their
brighter tomorrows to keep the pot boiling. Unfortunately, those
tomorrows never came. During this same period, drug industry growth
was fueled by a rich, untapped seam of market demand opened by the
advent of direct-to-consumer pharmaceutical advertising. Nonetheless,
with patent lives winding up and the new markets becoming saturated
with me-too competitors, the industry's all-eggs-in-the-basket blockbuster
strategy finally started to sputter - hence the financial Viagra
employed by Merck and BMS.
The latest gambit to manufacture growth could be called phago-pharmacosis:
gobbling up the competition in a spate of mega mergers. Besides
the proposed Pfizer/Pharmacia deal, rumors are rife about GlaxoSmithKline
wedding Bristol Myers Squibb (creating an acronym that sounds like
a broad alliance of sexual minorities). A GSK/BMS combine would
be particularly alarming for those dependent on HIV treatment. This
would hand the super company a monopoly on the nucleoside backbone
of combination antiretroviral therapy. What impetus would there
be to innovate if you already own a piece of every viable AIDS regimen?
Legal challenges will surely greet any attempt to create this unhealthy
union.
And there's no evidence that bigger pharma companies are better
pharma companies. The industry in general is suffering from a dearth
of new drugs and the last wave of mergers hasn't seemed to help
the situation. By Hank's math and PhRMA's estimate, at a $100 million
a week, Pfizer should be pumping out a new drug every two months.
But aside from an enhanced lobbying presence in Washington, where's
the advantage of size? In contrast, a truly innovative new HIV drug,
T-20, developed by tiny Trimeris with the help of Roche, is expected
to come to market next year after only about $500 million invested
in R&D over the past nine years. Many of the industry's best
new ideas are coming from similar boutique biotech companies who
license out their discoveries for the majors to turn into major
medicine.
Stock prices for a number of the pharmaceutical giants peaked about
two years ago and have been sliding since with no signs of a rally.
Most analysts say the problem is the pipeline. Against this darkening
sky, the perceived threat to intellectual property and pressure
on international drug prices from generic HIV medications began
to rise. Mix in a growing price backlash in the domestic political
sphere, and the industry's traditional mask as the beneficent bringer
of health and life had to crack. It was time to play hardball in
the courts of law and public opinion. Yet despite the best efforts
of PhRMA, both tough and treacly, the tide of events has continued
to run away from them.
But consider a different, more idealistic, view. It's possible
that a scaling down of profit expectations may actually help the
pharmaceutical industry get back to what Hank says he would like
to see - a focus on its core competency of serving patients by making
and selling better, safer drugs. While drug research costs are significant,
they are but a fraction of what has been flowing into the profit
column during the past decade. (In 2001, Pfizer claimed 24 percent
of its revenues as profit; it spent 15 percent on research.) Despite
declining revenue, why can't investment in research continue at
similar levels as long as profit expectations are attenuated? A
cooling down of the industry might allow the focus of research to
shift from serving the bottom line to serving patients' unmet needs.
The urgency to produce only high-margin blockbuster drugs should
be retired; that approach hasn't worked anyway - it's turned out
to be a drag on profit. Why can't research into a broader range
of drugs to treat a broader range of needs be justified - and made
profitable?
If serving the patient is really what it's all about, then the
industry should welcome some of the reforms that Hank finds so threatening.
For example, although patents initially protect innovation, patent
terms that run on for too long may actually stifle new advancements.
Patent reforms that call for reducing the period of market exclusivity
might actually free industry to move forward to develop the next
good idea without waiting to milk every drop of profit from older
inventions. Too often we only see research supporting a new indication,
or an improved formulation, appear just as a drug's patent life
nears exhaustion. Customers suffer when they are denied access to
more tolerable formulations simply to keep market exclusivity alive.
Most big drug companies have reluctantly reduced their prices to
compete with those offered by generic makers in developing regions.
Soon, these drugs are going to start flowing to patients in increasingly
significant numbers. As these worldwide treatment programs come
on line, the number of people receiving ART in the world will double,
triple, and then balloon to a currently unimaginable size. Many
funders, such as private sector providers, will specify competitively
priced branded drugs in their treatment programs. The tremendous
volume of drugs sold, even at razor-thin margins, may be able to
generate considerable profit. And these millions of people on treatment
will have been transformed into something the industry values very
much indeed: consumers of pharmaceuticals.
The international generic makers deserve credit for spurring the
coming revolution in access. But they are not just copycats. The
big generic makers employ their own pharmaceutical chemists and
they are slowly starting to add value to the molecules they manufacture.
New, more practical, combinations of HIV drugs, such as AZT, 3TC
and efavirenz in a single pill are available from generic makers
- combinations that would never be made if left to the branded makers.
Additional creative combinations and perhaps even improved formulations
can't be far behind. The "quality card" often played by
PhRMA is of legitimate concern. But there is no reason why the quality
of drug product output by new purpose-built factories can't actually
exceed that produced by the aging plants of the majors. Earlier
this year, Schering-Plough was sanctioned for quality lapses in
its Puerto Rican factory. If generics are offering better choices
at a better price, then isn't the customer well served?
Finally, as generic makers gain expertise and clinical experience
with state-of-the-art drugs, we can expect to see research innovations
as well. Last year, Dr. Reddy's Laboratories, an Indian generic
maker, licensed original discoveries to a branded pharmaceutical
maker for clinical development. It seems the tide of intellectual
property can flow both ways. If bloated pharma has strangled innovation
in its own labs, then maybe the research creativity of some surprising
new international partners may be part of the solution.
The future?
Down the road, many observers predict big changes in drug development
helped along by insights from the genomic revolution. These changes
could shake things up in ways that few have yet realized. As we
learn more about the genetic and functional basis of disease, exquisitely
tailored drugs may be designed to treat or correct medical problems
with unprecedented efficacy and safety. An individual's genetic
profile might one day guide a doctor as she prescribes drugs that
have been designed to act in concert with that patient's blend of
genes. The mechanisms of toxicity will be better understood and
drugs might be custom selected that correct imbalances without creating
new disease.
The drug discovery process too will be dramatically different.
Already, drug companies are incorporating methods that screen for
known toxicities at the earliest stages of their search for chemical
compounds that might become useful drugs. AIDS drug researchers
are testing their promising compounds against a wide range of virus
mutants that have already become resistant to existing drugs. It's
no longer acceptable to go forward with a drug that can only act
against yesterday's virus.
One day automated arrays of assays using chip technology may allow
rapid multi-dimensional evaluation of thousands of compounds. And
as new chemical libraries of promising molocules are generated in
the light of our improved understanding of suites of interrelated
proteins (the proteome), several equally safe and effective drugs
might be developed that can provide nuanced treatment for genetically
diverse individuals and populations.
Herein are the seeds of a radical transformation of the pharmaceutical
industry as it has developed during the past 30 years. If there
is no one "best" drug for everybody, then the concept
of the blockbuster pharmaceutical product becomes obsolete. The
existing business model of paying for marginally profitable drugs
with the high profits from superstar exclusives will have to be
rethought. As our knowledge and capabilities improve, one size will
no longer fit all. Call it the boutiquing of the drug industry.
Of course, there may also be efficiencies from the coming technologies
that can help shorten discovery and development times and thereby
allow longer periods of patent protection and market exclusivity.
And if a suite of related compounds can move through the approval
process simultaneously, then the problem of dealing with a diversified
mix of "models" may not impede the marketing of the core
drug concept. But these are big changes to negotiate and will involve
an evolution in animal and clinical trial design as well as a set
of serious challenges for the FDA and other worldwide regulatory
agencies.
Hopefully, as the pharmaceutical industry sees its paradigm changing
from a purveyor of a few products to the millions, to a supplier
of the right product for the right individual, it will find itself
capable of - and rewarded by - serving a truly worldwide marketplace
with a diverse range of needs, genomes and abilities to pay.
Of course, if the discovery, development and delivery of new HIV
treatments ultimately devolves upon the shoulders of only two or
three consolidated pharmaceutical giants, then the crucial ingredient
of competition driving this fanciful future may evaporate. If that
becomes the case, then go light on the AZT... it may have to last
a long, long time.
AIDS 2002 Barcelona:
A Personal Perspective By Ikechuku Anya, MD London
School of Hygiene and Tropical Medicine
I arrived in Barcelona on the 1st of July to take part in what
was to be my first International AIDS Conference. The first thing
to strike me was the heat and humidity. As a Nigerian studying in
the UK, I had become quite used to the intemperate English climate.
Arriving in Barcelona, the first blast of moist heat propelled me
back to hot, humid Lagos.
I was volunteering on a pre-conference workshop for journalists
organized by the National Press Foundation and the communications
office of the conference. It was a great experience, interacting
with journalists, activists and scientists from all over the world.
It was interesting to see the different perspectives and dimensions
to HIV/AIDS from the scientists angle, as well as the journalists',
from the North to the South and so on.
I also realized that the weather was not the only thing Spain had
in common with Nigeria. The inefficiency and bureaucracy made life
very difficult for the workshop organizers. The sheer difficulty
in getting someone who could speak English at several points made
making very simple requests a complicated drama. For instance, a
consignment of conference bags was held up at the airport by Customs
allegedly because the declared value ($200) was too high! Watching
Donna, Director of Operations for the National Press Foundation,
working the phones to sort out this seemingly minor problem was
almost hilarious.
She would ring the airport, and ask to speak to someone who could
speak English. They would ask her to hold on, in Spanish, leave
the phone for a few minutes and then drop it. After several attempts,
an English speaker would be procured who would then give another
number for the Customs desk. With the Customs desk, the same charade
would be replayed and then another number for the courier company
would be offered. And so on. It was amazing no one suffered a nervous
breakdown. It was that frustrating.
The media workshop over, the conference proper began. Here again,
I was volunteering in the PWA (Persons with HIV/AIDS) lounge, which
was an extremely rewarding experience. Talking and interacting with
PWAs of every nationality, age, gender, religion, profession and
orientation brought home most vividly how truly global the HIV problem
is.
In the lounge, I met many fellow Nigerians bravely living with
HIV who had come to the conference to add their voices to others
calling for universal access to antiretroviral treatment. It was
a privilege to meet people like Georgiana Ahamefule, the first Nigerian
to sue the employers who sacked her after discovering she was HIV
positive. Similarly, meeting the very friendly and intelligent Judge
Edwin Cameron of the South African Supreme Court, who is a symbol
for PWAs everywhere, was an experience. There were of course less
agreeable aspects to working in the lounge. The unavailability of
a broad menu, the difficulty in accessing the lounge and poor logistics
on occasion made the situation there sometimes difficult. However,
the friendly, hardworking team of volunteers made the work easier.
The opening ceremony was, as expected, a spectacle. Held at the
breathtaking Palau St. Jordi, it was preceded by a huge demonstration
in favor of universal access to treatment. The presence of activists
at the conference was very evident from the beginning and this resulted
in the Spanish Minister of Health being steadily booed throughout
the 10 odd minutes of her speech. Sadly at the end, she lost her
temper and banged her fist on the lectern, which only produced more
jeers. Apparently she was being booed for a less than efficient
approach to HIV control in Spain and the difficulties experienced
by many delegates in obtaining visas for the conference. The presence
of the Infanta Elena, daughter of the King of Spain, did not deter
the activists.
The strong visibility of activists developed further during the
Conference with Act-Up Paris closing down some drug company stands,
notably Roche and GlaxoSmithKline, for restricting or delaying universal
access to lifesaving antiretroviral therapy. One was always being
pressed to accept a sticker or badge supporting various viewpoints.
Those that spring immediately to mind were the Terence Higgins Trust's
"End the Ban" sticker opposing travel restrictions for
HIV-positive people to the U.S., and the "Microbicides Now"
lobby demanding greater research and investments into microbicides
which would empower women. The World Council of Churches also protested
the lack of a worship and meditation space at the conference.
Scientific meetings were many and varied and it was often difficult
to choose which sessions to attend. The news on vaccines was cautiously
promising, as were newer approaches to prevention. Brazil presented
results from its antiretroviral program, effectively debunking the
myth that such a program was impractical in a developing country
setting. This became one of the recurring themes at the conference
as speaker after speaker, including Peter Piot, UNAIDS director,
urged global commitment for the funding required to make universal
access to treatment a reality.
The plenary sessions were also thought provoking, at least the
two I was able to attend. The speaker who made the most impression
on me was Kasia Malinowska-Sempruch, who painted a grim but vivid
picture of the twin plagues of HIV and injecting drug use sweeping
through her native Poland and the rest of Eastern Europe. She called
on the world to learn from the situation in Africa and act before
it is too late. The poster displays were huge and it was difficult
to take in more than a very little of what was on display, especially
in the hot and humid Barcelona weather.
There were also receptions and launchings organized by various
interest groups. I was particularly sad to miss the breakfast meetings
of the African-American AIDS Policy and Training Institute which
paraded a host of notable speakers, but they started at 6:30 every
morning, and dinner in Barcelona tended to be at about 10:00 pm,
making it very difficult.
Of course there was a very lively social and cultural program,
and there were brilliant opportunities for networking. I was particularly
pleased to meet many Nigerians active in the field, whose names
I had been familiar with but had never met, and to meet many old
friends and colleagues. We shared a few nights eating pounded yam
and egusi soup at a Nigerian restaurant when the paella and other
Catalan culinary delights became too much for us.
The closing ceremonies which featured Nelson Mandela and Bill Clinton
as lead speakers were soul stirring. Before the ceremonies started,
some members of the South African delegation treated us to an impromptu,
uplifting song and dance session. In the very left-of-center atmosphere
that prevailed throughout the conference, Clinton and Mandela were
very warmly received.
Clinton's speech ended with a chant of "Four more years"
from a group of Americans sitting behind me as he spoke eloquently
and passionately with his characteristic charisma. Some delegates
wondered though why he had not done more for HIV while still in
office. Mandela spoke with his characteristic deep wisdom, speaking
out boldly in support of the conference themes but also advising
a re-evaluation of strategy on the part of the AIDS lobby.
On the whole it was a unique experience, totally different from
other scientific meetings, because it brought together scientists,
social scientists, clinicians, activists, journalists, human rights
and patent lawyers, PWAs and a host of different people.
What was difficult to shake off and perhaps disturbing was the
air of jamboree that hung over the whole conference. Amid all the
hugging and chatting, networking, hustling for funding and heavy
handed drug company marketing and playing to the camera-activism,
one was slightly sobered by the thought of the millions out there
daily living under the shadow of HIV. At times, it was difficult
to make the connection.
Reproduced from the Nigeria-AIDS eForum, the email discussion
forum of Journalists Against AIDS (JAAIDS) Nigeria. To subscribe,
send an email to: eforum@nigeria-aids.org
or visit: www.nigeria-aids.org.
Private Sector
Responses By Bob Huff
Studies of the cost effectiveness of treatment versus prevention
found little respect at this conference. The assumptions used in
several models presented ranged from inadequate to laughable. One
hapless economist was shouted down by a member of ACT UP Paris while
showing an analysis that counted the value of the life of a South
African who dies of AIDS as equivalent to $100 in lost tax revenue.
(Masaki E, TuOrG1248)
Although decision makers may consult cost/benefits analyses, it
was clear that the decision to offer therapy encompasses many factors
that may trump the bottom line.
Steven Forsythe of the Futures Group, a technical consultant to
governments, non-governmental organizations (NGO) and businesses,
reported the findings of a study contracted by a large multinational
corporation to assess the feasibility of offering ART to its HIV-positive
employees, spouses and children. The cost of treatment was compared
to the impact on productivity to see if there would be a direct
economic benefit for the company.
The assessment considered three regions, of low, moderate and high
HIV prevalence. East Africa, a region with 22 percent prevalence,
served as the model for an area where treatment costs were expected
to be highest. For this company, it was estimated that eight new
patients would come into care each year in its East African operations.
The lifetime cost to the company under its medical plan for an East
African worker with no access to treatment was estimated to be $4,500.
The model predicted that the cost in lost productivity and direct
costs of care from AIDS would be highest in the company's management
strata, with 46% of overall costs coming from only 15% of the affected
workforce. The distribution of costs was estimated as 48% among
workers, 41% among spouses and 11% among their dependent children.
The annual cost to the company for treating its employees in this
high prevalence region was estimated at about $62,000. The model
assumed that ART would add five years of life, with death delayed
from year one to year six. With the provision of ART, the model
predicted net savings during the first year, due primarily to the
deferred costs of death and job retraining. The costs of death included
end-of-life care and burial expenses. After the first year, however,
the model predicted that costs would outweigh the savings benefit.
In this East African example, the model predicted that the cost
of providing treatment would be approximately three times the savings
benefit, a ratio of .29/1.00. For lower prevalence regions, the
cost/benefit ratio was more favorable. The economists reported that
for this multinational company's East African operations, the economic
benefits of offering ART to its employees would not outweigh the
costs. Nonetheless, the company determined that since providing
ART was affordable and offered other, unmeasured benefits, it would
make the decision to provide treatment to all of its employees.
Forsythe stated that the role of the economist was simply to provide
estimates of both the costs and benefits as well as the affordability
of ART. Armed with this information, the company decided to treat.
(Forsythe S, TuOrG1245)
Although Forsythe didn't identify the client, it was assumed to
be the multinational beverage maker and distributor, Heineken. In
a subsequent session, Heineken official Stefaan Van der Borght discussed
his company's decision to offer ART, their experiences with the
program, and the challenges they still face. The company's management
decided that one of the key criteria for moving ahead with providing
ART was that any program should remain sustainable once begun. Heineken
has been doing business in Africa for over 70 years, said Van der
Borght, and in this context the decision to provide care was understood
to mean a long-term commitment and therefore not to be taken lightly.
He said that businesses are generally well prepared to undertake
treatment programs because of policies and accountability systems
that are already in place to administer programs with verifiable
standards and quality controls.
Heineken began its program by establishing several principles:
first, no discrimination would be allowed based on serostatus. Second,
confidentiality would be strictly maintained. Next, all workers
and their partners were to be treated with no distinction made between
management and other workers. And once treatment had begun, a commitment
was made to continue it, despite layoffs or illness. Finally, no
suboptimal regimens would be used; treatment must be in accord with
WHO guidelines.
To date, Heineken's operations in Rwanda and Burundi have provided
treatment for 45 persons, with an estimated 10 deaths having been
averted. The program will be expanding to new territories soon.
According to Van der Borght, several enabling factors helped Heineken
management make the decision to offer ART.
- A preexisting culture valued sustainability of the company in
the region and placed stability over short-term profit.
- There was a willingness to provide leadership for the business
community on this issue.
- The company determined that it had the capacity to absorb the
costs involved and that adequate medical facilities were already
in place to implement the program.
- Finally, the decision makers had known people with AIDS and
most had been personally affected.
While the company was studying the issue, the price of drugs began
to fall considerably, a development that enabled confidence the
company could afford to mount a quality program. This last factor,
Van der Borght noted, has been instrumental in stimulating other
companies to start offering treatment to their employees. He also
noted that the cost/benefit analysis was thought to be less meaningful
than the affordability of the program.
The cost per treated employee is currently pegged at about $1600
per year with about half of the company's seropositive employees
currently electing treatment.
Yet several obstacles remain, with the difficulty of managing treatment
first among them. The cost and complexity of laboratory monitoring
is also difficult, according to Van der Borght. The company has
also recognized a conflict between the principle of confidentiality
and proven methods to enhance treatment adherence such as directly
observed therapy (DOT) provided in the workplace. And in very poor
regions, where simply having a steady job sets one apart from most
people, the added benefit of access to ART only increases that gap.
Relations with governments have also been less than ideal. Often
government officials will agree in principle with the program but
fail to participate meaningfully. In particular, Van der Borght
said, it is difficult to obtain written commitments, perhaps because
government officials are embarrassed by their own inability to offer
their employees ART. Often when cooperation is offered, it is with
strings attached that attempt to shift control away from the company.
Other practical problems include assuring that drugs are registered
and available for legal import - the company has actually been faced
with paying to expedite registration. For available drugs, stock
supplies may be erratic due to changes in import mechanisms or,
in one case, a drain on the expected drug supply when the army demanded
first access.
The program has also experienced resistance from conservative medical
providers who do not understand or believe that HIV can be treated.
There is also the perception that if the company is providing this
benefit then it must have unlimited financial resources; the program
attracts much interest but little support from other actors. For
example, NGOs seem reluctant to cooperate with the private sector
and company officials are rarely invited to meetings about coordinating
HIV care in the region. So far, the UNAIDS Accelerated Access Initiative
has offered little assistance with supply lines.
Yet Heineken believes there are untapped benefits from public/private
cooperation. Operational research involving the private sector could
rapidly discover easier and more efficient ways to provide treatment.
And, at the very least, governments could take a greater role in
facilitating the success of such programs.
One cost-cutting avenue that Heineken will not pursue for the meantime
is the use of non-branded medications. As a branded entity itself,
the company has a policy to respect brands and not use generics.
Although, Van der Borght says, this position could change if a government
where they do business eventually offers an acceptable standard
of care for its citizens that includes the use of non-branded ARVs.
(Van der Borght S, ThOr247)
| Short Course |
Notes on HIV drugs in development |
|
FTC breaks out
Triangle Pharmaceuticals has announced the surprise early
unblinding of their FTC-301 trial of coviracil (FTC), a nucleoside
analog. The trial compared FTC head to head with d4T, both
in combination with efavirenz and ddI. A data safety monitoring
board took an early look at the data and decided to end the
study due to superiority in one arm. The trial was unblinded,
coviricil crowned, and now all participants will be offered
FTC.
Triangle says it is currently preparing to submit its FTC
licensing package to the FDA in September. If the agency decides
to expedite approval, a decision could be reached within six
month.
In a simultaneous news release, Triangle announced that they
have severed their marketing relationship with Abbott Pharmaceuticals.
Under the agreement, Abbott would have brought FTC to market
through a well-established sales force already servicing Kaletra.
The companies claim this parting of the ways was due to a
divergence of interests, with Abbott now pursuing protease
inhibitors and hepatitis C treatments, and Triangle going
for nukes and hepatitis B drugs. Triangle currently has no
sales apparatus, so it remains to be seen if they try to go
it alone or cut a deal with another pharma giant.
FTC has a very forgiving, long half-life and should make
a practical once-a-day drug. One radical marketing strategy
might be for Triangle to license FTC for co-formulation into
a fixed dose combination with a compatible drug such as efavirenz
or tenofovir. Radical!
T-20 expanded access limps forward
In a conference call with community members, Roche Pharmaceuticals
revealed their plans for wider release of T-20 through an
expanded access program. So far, about 305 people are receiving
the drug through a pilot safety study. Current plans (and
there have been so many it wearies me to type this) call for
greater drug availability on October 1. The company expects
about 600 slots to open up in the U.S. with this new program.
Although the hoops that doctors must shimmy through have been
minimized, a hitch may come when providers learn they have
to complete a full day's training on proper T-20 administration
technique. Because T-20 is a fragile peptide that must be
carefully reconstituted with sterile water before using (swirled
not shaken!!), this training isn't a bad idea. Access won't
be worth a hoot if patients fail to benefit from the drug
because they never learned how to prepare and inject it properly.
The company has promised to review all of their enrollment
procedures once again and cut the fat. That said, no one who
has followed this enduring saga of gaining access to T-20
will be surprised if the debut is slow and sludgy. Roche expects
to go to the FDA with their bid for approval before year's
end. This one will surely be fast tracked, and it may be a
horse race to see who gets the drug first: the expanded access
enrollees or your neighborhood pharmacy. |
As Time Goes
By (Millions Die) By Bob Huff
My personal take on this conference is clouded by a sense of disbelief
that the Durban meeting actually happened two summers ago - not
one. In Durban the struggle was clear: global access to treatment
was necessary and inevitable. But powerful opposition forces had
to be pushed out of the way first: The big funders, who only saw
cost effectiveness in supporting prevention; the big drug makers,
who only saw a threat to patents and profit; and a host of big jerks
who didn't believe Africans could learn to take pills or tell time.
In Barcelona these forces were, if not absent, at least discredited
and pushed underground. But it's taken two years to get over that
obstruction, and of course now, a mountain lies ahead. The World
Health Organization (WHO) has articulated a goal of extending treatment
to three million people in the developing world over the next three
years - a period in which over nine million more will die. There
may be no roadmap for the journey, yet the clear consensus at this
conference was to put one foot after the other and march.
Durban was different in so many ways. In Durban we rallied with
Winnie Mandela. In Durban we marched with the proud HIV-positive
people of TAC! I knew Barcelona would not be like Durban; in fact
I was counting on it. I had hoped for a boring conference, full
of detail and best practices about how many small programs and communities
were starting to offer treatment and hope. The level of intention
was very high but examples were few and mostly familiar. In Haiti,
Partners in Health continues to prove communities and families can
play a crucial role in making ART work, even where CD4 counts are
scarce. Brazil's successful program to treat its people with HIV
is the grand exception and still accounts for half the number of
patients receiving treatment outside of the rich northern countries.
At their satellite session, Medecins Sans Frontieres (MSF), which
has been so important in rallying opinion around the world to demand
affordable access to essential medicines, presented a farmer from
Malawi named Fred, who powerfully made the case that treatment dispels
stigma - that what people really fear is their own death - not the
disease. When neighbors see people virtually "return from the
dead" they see hope and are more willing to provide care, understanding
and even get tested. However, MSF's report on their treatment programs
gave less insight than I'd hoped about how they've managed to place
750 people on ART in nine sites around the world. More instructive
were presentations by private sector entities who have undertaken
offering ART to their employees. In particular, the Danish brewer
Heineken reported fully about its experience in researching options,
arriving at the decision to treat, formulating policies and deploying
a program. In East Africa last year, the company estimates their
program averted the deaths of 10 employees.
So it's been slow going and not likely to change overnight. I'm
torn between anger at the glacial pace of process and admiration
for the patient persistence of those who press ahead. As small,
successful efforts by community-based organizations (CBO) and non-governmental
organizations (NGO) scale up, I'm becoming nervous that the produce
of bureaucracy - of needs assessments, deliverables, accountability
and programmatic goals - may come to stand for action and progress.
Funders have a responsibility to see that the money they provide
is well spent, but as we heard in a satellite session sponsored
by the NGO/CBO support program, International HIV/AIDS Alliance,
those expectations come with costs attached.
Milly Katana of Uganda, a board member of the Global Fund for AIDS,
Tuberculosis and Malaria (GFATM), said that NGO support mechanisms
need to change their orientation. "Currently, support systems
are designed for North-South relationships. NGO support systems
need to build South-South mechanisms. Northern-based agencies have
almost UN program status - which is costly." When funders ask
about auditing and organizational structure it can hurt the local
enthusiasm for acting, which is the core capital of most groups.
These structures may reassure funders but the expectation of accounting
systems can also slow down responses. If a group deserves money
because they have a creative way of working with young homeless
people, how much time and money should they spend preparing reports?
An audience member proposed that grants should come attached with
the overhead and technical assistance that will be needed to satisfy
accountability. "Don't make reporting demands lightly without
providing funding or you risk turning service organizations into
reporting organizations."
Tim Lee, who works in Zimbabwe asked, "Can donors be more
flexible? Could they accept programs and results in lieu of reports?
Maybe some groups should stay as informal groups - not everyone
needs to become an NGO. The important thing is that CBOs are able
to do what they do what they do best."
Katana asked: "Why is this such an issue? How do uneducated
people in the community manage money for their families and businesses?
They do it!"
All this stands in stark contrast to Tommy Thompson's thoughtless
assessment that, "The worst thing would be to put money into
programs that fail." But in the Ukraine, with incidence rates
up 1300%, the worst thing is already well underway.
One audience member commented that it might be time for funders
to ask something different of their beneficiaries. Not "Where
did every penny go last month?" but "How many risks did
you take last month? CBOs should be encouraged to try things and
fail. Maybe the expectations of funders will have to change."
In his plenary talk opening the Barcelona conference, Peter Piot
of UNAIDS marked this meeting as a staging ground where the world
embarked upon action: "We didn't come here to renegotiate commitments.
The next World AIDS Conference in Bangkok will be the time for accountability.
Now is a time for a movement to turn up the heat."
Three Million
in Thirty-six Moons
By Gregg Gonsalves
According to the World Health Organization (WHO), six million people
living with HIV/AIDS need treatment today. Yet, as of July 2002,
only 230,000 people in the developing world have had access to antiretroviral
therapy (ART). Half of these people live in Brazil. In Africa, there
are fewer than 50,000 people estimated to be currently receiving
ART. WHO has bravely targeted 50% coverage of ART by 2005. That
means 3 million people could be on HAART in 3 years, a more than
10-fold increase in the current figures. Bob Huff, in this issue
of Treatment Issues, has called this WHO's "moonshot
challenge."
The year 2002 has thus become a pivotal point when the fate of
millions of people living with HIV is decided. Will we collectively
take up this challenge or will we ignore it? I think we have no
choice but to answer WHO's call. Without immediate action, the six
million who need treatment today will be dead soon enough, and 70
million will die of AIDS by 2022. Challenges like this can only
be made once; such dramatic goals do not stand up well to failure
- we won't be able to say "let's try it again" in 2005,
if we haven't made substantial progress by then.
Unlike many of the moonshot challenges that have been made during
the AIDS epidemic such as the call for a vaccine by 2010 or a Manhattan
Project to develop a cure for AIDS, this task doesn't depend on
the serendipity of science to offer us our "holy grail."
We are facing a logistical problem, albeit a massive one: how do
we get the existing drugs to the people who need them? With enough
resources and a gigantic mobilization of people and expertise, we
can treat 3 million people in 3 years.
According to the Congressional Budget Office, the war in Afghanistan
probably will cost $10.2 billion this year. I am mentioning the
war in Afghanistan not to make a guns-into-butter appeal to the
U.S. government, but to just document the scale of what we need
to have happen, and a current example of a successful mobilization
of this size.
We need to get busy. Before the end of this year, there must be
a roadmap in hand for getting us to our goal of treating 3 million
in 3 years. This roadmap needs to offer a comprehensive plan for
action: from procurement and delivery of drugs and associated products
(e.g. diagnostic tests), to technical assistance; from financing
options, to education and mobilization efforts for people with HIV/AIDS;
from resistance surveillance to recruitment, training and retention
of health-care workers...the list goes on and on.
We also desperately need leadership. While the Barcelona AIDS conference
was notable for the emergence of a new, unequivocal consensus on
the urgency of delivering treatment to the millions of those who
need it, a plethora of different efforts and initiatives have now
been launched or are in the planning stages. An effort on the scale
of what the WHO is suggesting needs a "general," or at
least someone with experience and expertise in large public health
initiatives to push this forward. We should look to individuals
with experience in scaling up public health programs for other diseases,
including TB, river blindness, trachoma, polio, smallpox and malaria
or even to people who have experience outside of the health field
in large-scale mobilizations, yes, including military leaders -
real generals.
Finally, while the resources for treating 3 million people in 3
years will come from a variety of sources, including the Global
Fund for AIDS, TB and Malaria, the United States will have to pony
up a significant chunk of the resources for this task. So far, the
Bush Administration has done almost nothing towards promoting access
to treatment in the developing world. With a new global consensus
on treatment, it's time for President Bush to step up and lead.
It can be his "Nixon in China" moment, where the unlikeliest
of characters can make history, and in this case save millions of
lives.
In his speech during the opening plenary at the Barcelona conference,
Bernhard Schwartlander, the new chief of WHO's AIDS program, made
a plea to the assembled audience: "The time for excuses has
run out. Challenges remain - that's why we're here. But the pieces
are finally coming together. Two years from now, when we meet again
in Bangkok, let this presentation look not simply at the number
of new infections, but how many lives we have saved."
We need to answer WHO's rallying cry and run forward to join this
fight.
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