
AIDS TREATMENT NEWS Issue #249, June 21, 1996
   phone 800/TREAT-1-2, or 415/255-0588


CONTENTS:

New Optimism on Controlling HIV Infection

Internet Free Speech Wins Court Test

Azithromycin Approved for Once-Weekly MAC Prophylaxis

Nevirapine Recommended for Approval

Free Viral Load Tests: Remember to Dial 1 Before 888

Needlestick Exposure: CDC Recommends Three-Drug Regimen

AIDS and Alternative Medicine: A Journalist's Perspective


***** New Optimism on Controlling HIV Infection

by John S. James

Today there is more optimism among leading experts about the 
prospects for controlling HIV infection than at any previous 
time in the AIDS epidemic. This change (illustrated by a 
recent conference, "Can HIV Be Eradicated from an Infected 
Individual," June 12-13 in Washington, D.C., organized by the 
University of Amsterdam and the journal ANTIVIRAL THERAPY -- 
and by a major page-one article in the June 14 WALL STREET 
JOURNAL) does not reflect any single breakthrough, but rather 
a number of clinical research findings, which together are 
strengthening an approach to treatment strategy which began 
coming into public view a few months ago. It is important to 
understand the limitations as well as the promise of this new 
approach.

In late January of this year, at the Third Conference on 
Retroviruses and Opportunistic Infections, early data from at 
least two small trials suggested that, under ideal 
conditions, certain drug combinations could reduce all 
evidence of viral replication to undetectable levels in most 
patients. And the proportion of patients achieving this 
success seemed to increase over time -- the opposite of 
previous experience with anti-HIV drug treatments, which 
quickly reached a peak of viral suppression and then steadily 
lost effectiveness.

Today there is more data, and from different kinds of 
patients, suggesting that:

(1) Under ideal conditions -- meaning that treatment is 
started early, using certain antiviral drug combinations, in 
patients who are previously untreated (at least with all of 
the drugs in that combination), and with patients who can and 
do comply with the treatment regimen by using the drugs as 
directed -- HIV replication in many patients can indeed be 
reduced to levels which are completely undetectable by any 
test known, for prolonged periods of time. No one knows how 
long this essentially complete shut-off of viral replication 
will last, because the trials are only running now; but in 
most of the patients who can achieve this suppression and who 
can continue using their treatments as directed, there seems 
to be no evidence yet that this antiviral success is coming 
to an end. Some people have been on treatment in the studies 
for well over a year.

(2) If viral replication can be reduced to undetectable 
levels, patients do not progress to more serious disease, in 
the time frame seen so far. Again, no one knows how long this 
will last, since there is no long-time experience yet with 
patients whose viral load has been greatly suppressed by 
drugs.

Also, there are anecdotal reports of substantial improvements 
in ongoing AIDS-related symptoms in some of the patients. 
(There is no scientific data yet on this finding, as trials 
designed to address this question have not yet been run).

The viral load in these patients is lower than that in long-
term nonprogressors, who remain disease-free for many years, 
possibly indefinitely in some cases. But the number of 
persons who are naturally long-term nonprogressors (without 
treatment) is low, probably about five percent or less. By 
contrast, it appears that currently available drug treatments 
-- when used under ideal conditions -- can suppress all 
evidence of viral replication and disease progression in most 
patients, for an unknown period of time.

(3) The major problem in treating HIV has been that the virus 
develops resistance to all known drugs, causing treatments to 
lose effectiveness. It has long been known that the time 
required for resistant virus to develop varies greatly, 
depending on the drug. For example, with nevirapine (an 
experimental treatment recently recommended for approval by 
an FDA advisory committee), high-level resistance occurs very 
quickly if the drug is used alone. But AZT resistance 
develops more slowly, and some patients can use that drug for 
years without it happening (although there is increasing 
concern about people being infected with virus which has 
already become resistant to AZT -- and also concern that some 
AZT-resistant viruses may be more harmful than most non-
resistant viruses, even aside from the problem of loss of 
effectiveness of AZT).

But now there are trials of antiviral drug combinations 
active enough to reduce viral replication to undetectable 
levels in many patients. And it is being learned that when 
viral replication is reduced to a low enough level, the 
development of drug resistance is greatly slowed, or possibly 
even stopped. The example of nevirapine shows how large this 
difference can be, since resistance develops rapidly if used 
as a single drug or a single addition to ongoing therapy. But 
in the right combinations, for patients previously untreated 
with any of those drugs, nevirapine appears to be useful for 
a long time.

(4) Like almost all treatments for infectious diseases, this 
approach works best when treatment is started early -- and 
when patients do not already have resistance to any of the 
drugs in the combination they are starting (either from 
previous use of a drug in a dose which was not effective in 
shutting off viral replication, or by infection with virus 
which was already resistant). But there is no known reason 
why the same approach could not also work in advanced 
patients who have had many previous treatments, provided that 
some way could be found to reduce viral load to a low enough 
level. The problem is that it will be more difficult to find 
drug combinations which can do this for persons with more 
advanced HIV disease. This is why it is important to develop 
new and more powerful drugs, and better information about how 
to use them in combination, and about what treatments work 
best for different kinds of patients.

The emerging view of experts today is that what counts is 
getting the viral load very low and keeping it very low, 
regardless of how this is achieved -- whether naturally in 
persons fortunate enough to be long-term nonprogressors, or 
by whatever antiviral combination works for the particular 
patient. The more advanced the illness, the higher the viral 
load is to start with, the more drug-resistant viruses the 
patient already has, and the more problems there are with 
continuing the drugs and using them as directed, the more 
difficult it will be to get the viral load low enough. To 
maximize potential benefit, the emerging treatment philosophy 
is "hit hard and hit early."

How low a viral load is low enough? No one knows for sure at 
this time. A viral load which is and remains below the limit 
of detection of the Hoffmann-La Roche Amplicor HIV-1 
Monitor(TM) test -- the only viral load test currently 
approved by the FDA -- would seem to be a reasonable goal for 
now; for more information, see "HIV Viral Load Markers in 
Clinical Practice," published in NATURE MEDICINE, June 1996 
(reviewed in AIDS TREATMENT NEWS #248, June 7, 1996). [As we 
reported in our last issue, two free tests to establish a 
baseline are being offered to everyone with HIV in the U.S., 
but only for a 60-day period beginning June 17, 1996; for 
more information, call 1-888-TEST-PCR.]

Is Viral Eradication Possible?

If viral replication can be essentially completely suppressed 
for a long time, is it possible that the virus remaining in 
the body would eventually die, meaning that HIV was 
eliminated and the person could stop taking the drugs and 
would be cured? This is conceivable, but at this time there 
is no evidence that this is possible. Eventually some people 
whose virus is now being completely suppressed by antiviral 
drugs will try going off the drugs, and then we should find 
out quickly whether or not the virus comes back. (Two 
patients who had undetectable viral load for two months and 
four months did interrupt therapy, and the virus returned; 
this was reported by Dr. Luc Perrin, of Geneva University 
Hospital, at the recent HIV Eradication conference mentioned 
above.)

Although there is no evidence today that it is possible to 
eradicate HIV in an infected person, what is new is that the 
question is now open. Until recently, all drug regimens had 
been observed to fail with time; therefore, there was no 
possibility that any amount of those treatments could 
eliminate the virus. Today, with better treatments, we do not 
know. But even if it turns out that HIV cannot be eradicated 
just by suppressing it completely enough for long enough, the 
new results would still suggest that for many patients viral 
activity can be stopped for a long time, and drug efficacy 
maintained, with combinations of currently available drugs.

Comment: Practical Concerns

Most of the drugs being used in the new trials which appear 
to have largely shut off HIV replication in many patients are 
already widely available (in the U.S. and some other 
countries), by prescription or through expanded-access 
programs. The researchers running the trials have been 
unwilling to recommend particular combinations, since what 
counts is getting the viral load low enough, and the best 
drugs to use for this purpose will vary depending on the 
patient. Most of these regimens combine a protease inhibitor 
with at least two other antivirals. We will report results of 
particular drug combinations with particular patients as more 
information becomes available.

One of the practical difficulties in implementing the "hit 
hard and hit early" strategy, as the new results suggest, is 
that it means that people in early illness, who have no 
symptoms, are expected to begin long-term (possibly life-
long) therapy with combinations of at least three drugs. All 
these drugs can have side effects -- and all are expensive, 
and often inconvenient to use (as most must be taken twice a 
day or more, some on an empty stomach, others with food, 
etc.) How many people will be able and willing to begin and 
stay on such multiple-drug treatment, when they feel 
completely healthy, and may understandably be inclined to 
leave well enough alone? How many will be able to pay for 
expensive treatment (especially when their insurers see that 
they appear entirely well)? The new results seem to suggest 
that everyone who is HIV-positive should be on aggressive 
treatment with multiple antiviral drugs. But how realistic is 
this?

It seems to us that the widespread use of very early, very 
aggressive treatment will in practice usually wait until more 
evidence becomes available. Much more will be known by later 
this year. And it is possible that persons with a naturally 
low viral load might need less aggressive treatment to 
achieve the suppression required. It is also possible that 
after a period of suppression, maintenance therapy might not 
need to be as aggressive as the initial therapy. But this is 
only speculation until more is known.

Meanwhile, physicians and patients should re-think the 
unfortunately common practice of beginning HIV treatment with 
AZT alone, or with other regimens not strong enough to 
suppress the virus sufficiently. This approach is likely to 
lead to resistant viruses, which might make future treatment 
more difficult than if the inadequate treatment had never 
been started at all.


***** Internet Free Speech Wins Court Test

by John S. James

On June 11 a U.S. District Court ruled that the key 
provisions of the Communications Decency Act of 1996 -- 
against placing "indecent" or "patently offensive" 
communications on computers where they might be accessible to 
minors -- are unconstitutional because they violate the First 
Amendment of the Bill of Rights. Even though it is not final 
because the government is likely to appeal to the Supreme 
Court, this 39,000-word decision is immensely important 
because it explains the issues and the technology in a way 
that the legal community can understand. (The current Supreme 
Court, while conservative in many areas, has generally 
defended free speech.)

The June 11 decision does not affect the laws against 
obscenity and child pornography, which remain illegal on the 
Internet as elsewhere. But the "indecency" standard is much 
more far-reaching and vague than obscenity. For example, 
unlike obscenity, indecency "has not been defined to exclude 
works of serious literary, artistic, political or scientific 
value" (quotation from the court decision). The new ruling 
essentially gives the Internet similar First Amendment 
protection to what books, newspapers and other print media 
now have, instead of imposing the much more restrictive 
standards now applied to broadcast radio and television, 
which the Communications Decency Act would have done.

The decision includes an excellent summary of the technology 
and history of the Internet; we learned much from it. Also 
impressive is its review of the recent history of the First 
Amendment, and explanation of the reasons free speech is 
important in our system of government and society. The court 
also noted that there are effective ways to keep unsuitable 
material away from children, without restricting 
communication among adults.

The decision took particular note of the "market failure" by 
which both broadcast and print media have largely become 
controlled by a few large institutions, with most peoples' 
participation being passive -- and how the Internet is 
fundamentally different, with much lower barriers for entry, 
and essentially the same low barriers for speakers as for 
listeners. The Court clearly understood that the new law 
would have a disproportionate effect on individual citizens 
and on small organizations, while large corporations could 
protect themselves through expensive legal defenses, and by 
limiting their material to the mainstream viewpoints that we 
now receive through the broadcast and major print media. (The 
Court also noted that the new law would have little effect on 
commercial pornographers, who already exclude children by 
requiring credit cards for access to their materials, and 
therefore would not be much affected by the CDA.)

The historic importance of this ruling cannot be 
overemphasized, as many experts suspect that computer 
communication will become as important as the printing press 
in human cultural development. The new law would have 
effectively required adults to limit their use of this medium 
to communications suitable for children.

The case which led to this decision was brought by dozens of 
organizations and companies (in two separate legal actions 
which were later combined), including the American Civil 
Liberties Union, American Library Association, American 
Society of Newspaper Editors, Apple Computer, Microsoft 
Corporation, America Online, CompuServe, The Microsoft 
Network, and Prodigy. AIDS organizations included AEGIS, 
Critical Path AIDS Project, and The Safer Sex Page.

The decision provided sound bites which were quoted again and 
again in the media:

"The Internet may fairly be regarded as a never-ending 
worldwide conversation. The Government may not, through the 
CDA, interrupt that conversation. As the most participatory 
form of mass speech yet developed, the Internet deserves the 
highest protection from governmental intrusion."

The full text of the decision is available at various 
Internet sites, including http://www.aclu.org. AIDS TREATMENT 
NEWS followed the development of the CDA in issues # 227, 
229, 236, 237, 238, and 240.


***** Azithromycin Approved for Once-Weekly MAC Prophylaxis

On June 14 the FDA approved azithromycin (Zithromax(R)), 
adult dose 1200 mg taken once weekly, for prevention of MAC 
(MYCOBACTERIUM AVIUM complex) disease in persons with 
advanced HIV infection. According to Pfizer Inc., the new 
600-mg tablets will be available in pharmacies in several 
weeks.

Azithromycin has been approved in the U.S. for other uses 
since 1992. The new approval for MAC prophylaxis should help 
to educate physicians about this treatment option, and also 
help in getting reimbursement for the drug.

According to Pfizer, its drug "will be available at a lower 
cost than currently used MAC prevention therapies." The 
company has a patient assistance program to help some 
patients who need the drug and cannot afford it.


***** Nevirapine Recommended for Approval

On June 7 the FDA's Antiviral Drugs Advisory Committee 
recommended accelerated approval of nevirapine, an 
experimental antiretroviral currently available through an 
expanded-access program. The vote in favor of the drug was 8-
0. Official approval is almost certain; nevirapine will then 
be the first approved member of a new class of anti-HIV drugs 
(non-nucleoside reverse transcriptase inhibitors).

Nevirapine was recommended for use in combination with other 
antiretrovirals, because when the drug is used alone, viral 
resistance develops quickly. In triple combination with AZT 
plus ddI, it showed significantly greater improvement in CD4 
count increase, and in viral load reduction, than AZT plus 
ddI plus placebo, lasting at least for the 48 weeks the trial 
was run.

In a separate one-year trial with previously untreated 
patients, those on the triple combination of nevirapine plus 
AZT plus ddI had an average CD4 increase of 138 at the end of 
the trial (computing the average increase from weeks 40-52), 
and the CD4 count was still increasing after one year. 
Without the nevirapine, those on AZT plus ddI had an increase 
of 81 in the same time period (weeks 40-52), and their counts 
were decreasing. The difference between the 138 increase and 
the 81 increase was statistically significant. Also, about 
two thirds of those receiving nevirapine plus AZT plus ddI 
had their viral load reduced to undetectable levels.

An in-depth article on nevirapine, by Jules Levin of the 
National AIDS Treatment Advocacy Project, looks in more 
detail at the nevirapine clinical trial results -- and at 
safety, drug interactions, viral resistance, status of 
approvals internationally, and contact information for the 
expanded access program. This article is available on the 
World Wide Web at http://www.aidsnyc.org/natap; if you do not 
have Internet access, you can reach Mr. Levin by fax at 718-
624-8399, or by phone at 718-624-8541.


***** Free Viral Load Tests: Remember to Dial 1 Before 888

In our last issue AIDS TREATMENT NEWS published a toll-free 
phone number, 1-888-TEST-PCR, for patients or physicians to 
call for information about the availability of free viral 
load tests, using the Hoffmann-La Roche test newly approved 
by the FDA. Two tests are being offered to everyone in the 
U.S. with HIV, but only during the 60-day period starting 
June 17.

Some calls never reached the Roche hotline, but came to 
private homes and businesses instead. This happened because 
people did not dial the '1' to indicate a long-distance call; 
as a result, the first seven digits of the number were taken 
as a local call, and the last three digits were ignored.

The '888' area code represents a new toll-free phone number, 
presumably instituted because the familiar '800' numbers are 
running out. AIDS TREATMENT NEWS normally does not publish 
the '1' in front of a long-distance number, since people know 
to dial it. The current confusion occurred because '888' 
toll-free numbers are new. We will include the '1' with '888' 
numbers we publish in the future.


***** Needlestick Exposure: CDC Recommends Three-Drug Regimen

On June 7 the U.S. Centers for Disease Control and Prevention 
(CDC) published revised guidelines for antiviral treatment to 
reduce the risk of HIV transmission due to occupational 
exposure, such as needlestick injury with HIV-positive blood 
in a hospital or laboratory. The new guidelines are 
provisional, as little data is available.

Because the risk of transmission is low -- only about 3 HIV 
infections per one thousand percutaneous exposures to HIV-
infected blood, and because the antiviral drugs can have side 
effects, treatment is not recommended in very low risk 
situations (such as exposure to urine or saliva from HIV-
positive persons). When treatment is recommended, it should 
be started very rapidly, preferably within one to two hours 
of exposure. The treatment suggested is indinavir 
(Crixivan(R)) plus AZT plus 3TC for four weeks; however, this 
regimen should be changed in certain cases, such as with a 
patient likely to be intolerant to one of those drugs or who 
is taking incompatible medications.

The previous recommendation for occupational exposure to HIV 
called for treatment with AZT. A case-control study found 
that this use of AZT alone was associated with a 79% reduced 
risk of seroconversion. There is no human data on the 
effectiveness of combination treatment in preventing 
infection due to occupational exposure to HIV (since it takes 
a long time to get such data, because cases of seroconversion 
are rare). But all that is known suggests that combination 
treatment will probably be more effective than AZT alone.

The complete guidelines were published in the June 7 MMWR 
(MORTALITY AND MORBIDITY WEEKLY REPORT, of the CDC). 
According to this publication, updated information about 
prevention of infection due to occupational exposure to HIV 
will be available in early 1997 from the CDC's Internet home 
page (http://www.cdc.gov), and also by fax and telephone.


***** AIDS and Alternative Medicine: A Journalist's 
Perspective

by John S. James

Remarks to AIDS and Alternative Medicine: Current State of 
the Science, Bastyr University, Seattle, April 28, 1996:

I started AIDS TREATMENT NEWS 10 years ago, and the 
newsletter has now published 245 twice-monthly issues. When 
we started, we thought that AIDS TREATMENT NEWS would focus 
mainly on alternative/complementary treatments -- thinking 
that physicians and patients were already flooded with 
mainstream treatment information from journals and from 
industry marketing departments.

It did not turn out as expected. While some of our most 
important articles have been about alternative treatments -- 
for example, the September 1, 1995 interview with 
acupuncturist John Sinclair of the Immune Enhancement Project 
in San Francisco -- we have published many more articles 
about mainstream experimental treatments, or mainstream 
approved treatments, than about alternative approaches. 
Partly this is because the journals and pharmaceutical 
companies have done poorly in getting physicians the 
mainstream information they need, so most of our readers' 
questions concern mainstream treatments.

But also, there is much less research on alternative 
treatments, due to well-known funding difficulties. Research 
money, from government as well as from industry, is funneled 
preferentially into development of the most expensive 
treatment options -- a major though unrecognized upward 
pressure on the overall cost of medical care. Our reporting 
has been affected, because most of the new research findings 
have come from mainstream research. And we have felt 
compelled to focus on what is new, because no one has had the 
answer. Existing treatments, both mainstream or alternative, 
can be helpful, but most of the answers required to save 
lives will have to come from new research and development.

What has been lost from failing to research alternative 
treatments?

The big Vancouver international AIDS conference will happen 
in two months. After one of the earlier meetings, a physician 
from the developing world, who had just wandered through the 
high-tech exhibits and research reports, commented, "There is 
nothing for us here."

That is not surprising, since every medical tradition on 
Earth except for one has been excluded from any real role in 
developing new treatments. Only the corporate, high-tech, 
big-money, FDA-approved research process has been taken 
seriously. And this year at Vancouver there will be another 
issue: the unaffordability of the fruits of the big-money 
tradition, now that it is producing results arguably worth 
fighting for. Being excluded from AZT monotherapy seldom 
became a major concern.

But the loss is not only to the developing world, or to the 
excluded communities within the United States. For if there 
are important leads to new approaches within indigenous 
healing traditions -- and certainly there are -- we are 
unlikely to hear about them. Excluding almost everybody from 
the search for better treatments will slow that search 
greatly.

Major Problems in Drug Development

Some of the biggest problems in medical research and drug 
development affect mainstream and alternative alike. To 
simplify the recent history of drug development and approval, 
several years ago there were two major bottlenecks. One of 
them was obvious and painfully pressing, and has now largely 
been fixed, at least for AIDS. The other problem was more 
subtle, and it remains one of the major challenges for today.

When AIDS TREATMENT NEWS started reporting 10 years ago, the 
obvious bottleneck was in the late stage of drug development 
-- the later steps leading up to FDA approval. It was clear 
that clinical-endpoint trials were going to be required -- 
and that if a drug did work, it would take years for all but 
a few people to get it. The drug had to already look good 
enough that hard-nosed companies would invest many tens of 
millions of dollars in its development. And people could read 
about the drug in the newspapers, but could not get hold of 
it. This bottleneck, of course, affected only mainstream 
treatments, since anything which gets that close to approval 
would be considered mainstream by definition.

In most cases we do not have this problem in AIDS today. The 
current FDA leadership has developed regulations for 
accelerated approval, which allows a drug to be approved 
based on easily measured markers like CD4 and viral load -- 
and encouraged various forms of expanded access, which allow 
companies to provide a drug to many people before approval. 
The FDA now goes out of its way to find official, legal ways 
to make available AIDS drugs that the medical community as a 
whole has good reason to want to get. There are still 
problems, however: for example, expanded access can work 
commercially for some large companies, but others are 
uninterested, and for small companies it may be out of the 
question.

But the other bottleneck, early in the drug development 
process, has not been solved -- and it affects mainstream and 
alternative treatments as well. This bottleneck, which I 
believe is the fundamental problem in drug development today, 
is the difficulty of going from early work to the first 
credible human data on possible activity or efficacy.

In the case of mainstream treatments, the early work is 
usually in the laboratory. Treatment leads which show promise 
commonly do get published in mainstream, peer-reviewed 
journals. They get published because publication is the 
lifeblood of academic careers, so the researchers will fight 
to reach this stage. But then, in almost all cases, 
development stops cold, no matter how promising the 
laboratory results may be. With no human data, no one will 
invest millions of dollars which current rules usually 
require to be spent before that human data is available.

For alternative treatments, the bottleneck occurs after the 
treatment is already in human use, sometimes widespread human 
use, but there are no generally accepted scientific studies 
or data to support its benefit. Usually those studies never 
happen -- despite the obvious public health importance of 
researching treatments which are in widespread use, whether 
they work or not.

Part of the tragedy is that if a new drug or other treatment 
approach or idea could reach the stage of early data -- the 
first credible showing of activity in humans, even if less 
than a controlled trial -- then the existing system of drug 
development might respond passably well. Pharmaceutical 
companies, physicians, academics, and others will start being 
interested, and the treatment will have the momentum to carry 
it into further stages of research. But before it has that 
first credible human data, there is no sufficient evidence, 
no momentum, to start the ball rolling. Laboratory results, 
biological plausibility, or popular interest and use, have 
usually not been enough.

Much of the advance of medicine comes from lucky accidental 
discovery, in which the unexpected is allowed to reveal 
itself. Today's system poisons this well of potential 
discovery, by making research so cumbersome and expensive 
that it can only test ideas which already have widespread 
support in advance.

What Can Be Done?

How might research be organized to overcome this particular 
gap between widespread use of an alternative treatment, and 
widely credible data showing possible activity or 
effectiveness? We see several possible approaches. They are 
relevant not only to researchers, but also to physicians, 
patients, advocates, public officials, and potential donors 
who might support research.

* Use of viral load. Viral load testing, now widely used 
although not quite yet officially approved by the FDA, has 
made it far easier than before to tell whether or not a drug 
is working as an antiviral. A major antiviral effect would 
ordinarily show up in a few days, or a couple weeks at most. 
This means that the first human trials can now be far shorter 
than before. The treatments that don't work could be stopped 
within a couple weeks -- freeing resources to continue the 
trials for the minority of treatments which did reduce viral 
load, to get long-term data for them.

* Developing less cumbersome and expensive ways than 
controlled clinical trials to get credible initial data. The 
U.S. National Cancer Institute has published guidelines for 
"best case series" reports from physicians who use 
unconventional cancer therapies. And in surgery (where 
randomized controlled trials of operations are now being 
seriously considered) -- there is also interest in improving 
case series reports (see THE LANCET, April 13, 1996). The 
purpose of using case series is not to replace clinical 
trials, but to help make a preliminary judgment as to what 
treatments should go into the trials, which will be conducted 
at great financial and human cost.

* Investigating existing obstacles to credibility. For ten 
years AIDS TREATMENT NEWS has been answering phone calls for 
information about particular treatments. Often the calls come 
in groups; we will suddenly get a number of calls about some 
particular treatment, mainstream or alternative. We have had 
a chance to look at what is behind the calls.

For mainstream treatments, and sometimes for nutritional 
approaches as well, a flurry of calls usually means that 
research just published in a high-status journal was reported 
by major newspapers or TV networks. What is driving this 
interest is scientific discovery.

But behind a flurry of calls about an alternative treatment, 
in most cases, is not a scientific advance, but a marketing 
campaign to make money for someone. A new incarnation of some 
old pill or machine is being pushed.

Recently we used the Internet's World Wide Web to do computer 
searches on alternative treatments. We used a search engine 
called Alta Vista (described below), which immediately checks 
over 20 million existing Web pages for whatever words we 
specify, and returns results immediately. About 4,000 pages 
include the phrase "alternative medicine." But a great many 
of them were listings of health-food type products for sale. 
When we asked the search engine to eliminate all those that 
contained the word "product" or "products," we got the total 
down to a more manageable 2,000.

The fact that a product is commercially promoted does not 
mean it doesn't work. But it can make it hard for us to get a 
sense of whether it works or not. We do not know the people 
behind the campaign; do they believe in their own product? Do 
they have evidence, and are they evaluating it well? Or are 
they only pursuing a marketing challenge, in which their goal 
is to sell as much as they can, without any need to know 
whether or not it works?

Occasionally a flurry of phone calls or letters results not 
from a commercial promotion, but from activities of a true 
believer. Here the credibility problem is largely the same. 
It is hard to tell what you can trust and what you cannot.

The pharmaceutical-industry mainstream deals with this 
problem by having third parties, usually academic or clinical 
research physicians, conduct its research. While the company 
pays the money, the researcher's career depends only slightly 
if at all on whether there are positive results -- but 
depends centrally on a continued reputation for objectivity.

Perhaps the alternative-treatment world could borrow this 
system, too. The difference would be that we will never have 
the money that pharmaceutical companies have, and therefore 
must find research strategies which are far less expensive. 
This is possible, since most alternative treatments are 
already in frequent human use, so trials are much safer than 
those testing a new chemical entity which no human has ever 
encountered before.

But the history so far is not always promising. Often 
academics are misused in a way which constitutes a sale of 
their name for use in a marketing campaign. Hungry 
researchers or institutions which have a public reputation 
are hired to do some laboratory test or other piece of the 
research on an alternative product -- a test which has little 
or nothing to do with whether the product works as claimed. 
The academics do their job competently, but meanwhile their 
name is plastered on ads or promotional articles, to make the 
product appear to have credibility it would not otherwise 
have had. This practice complicates the search for methods to 
do the research right.

* Better standardization and handling of patient data. Much 
could be learned without the human and material costs of 
trials by analysis of data already generated in medical 
practice. But the data needs to be computerized, in ways 
which avoid unnecessary inconsistencies between the records 
of different practices. Then the data might be pooled 
anonymously -- or if that was not sufficient to protect 
confidentiality, researchers could get statistical summaries 
from the different offices and analyze those.

* More openness to and more equal communication with 
indigenous and traditional healers and traditions. Usually we 
will have to start our learning process on their terms -- not 
start with trying to force what they are doing into our 
preconceived scientific mindset.

Ultimately, to make knowledge widely transportable and 
useful, we will need to find credible ways of testing 
proposed approaches. But these ways need to be developed in 
collaboration. It will often not work to bring in a 
preconceived piece of scientific methodology developed in 
other contexts and for other purposes.

One potential resource for starting this learning process is 
ExtraMED, a new database created by the World Health 
Organization, of over 200 medical journals in developing 
countries. These journals are excluded from Medline, Embase, 
and other major bibliographic databases, and therefore 
largely unknown to researchers in the developed world. (For 
more information about ExtraMED, see below).

* Case studies of successful medical advancement. We can 
learn from history and analysis of important medical advances 
-- in the Western scientific tradition, but in other 
traditions as well.

* Building educated donor networks. We must be ready to 
explain research issues to persons who could contribute major 
support for research, but who may want to be sure that their 
money does not go down the same ratholes where so much has 
gone already. We need to learn what it is about a research 
project which disposes it to success, and what disposes it to 
failure -- and be ready to share this knowledge with others.

Appendix: ExtraMED Database

ExtraMED is a database of over 220 biomedical journals 
selected by the World Health Organization as among the best 
in the developing world. But almost all of these journals are 
not indexed in Medline, Science Citation Index, or any other 
Western indexing service. Therefore most researchers never 
find out about this published research.

An eye-opening article in the August 1995 SCIENTIFIC 
AMERICAN, "Lost Science in the Third World" by staff writer 
W. Wayt Gibbs, compiles appalling statistics on the exclusion 
of developing-country research from the world's scientific 
literature. A handful of indexing services have come to serve 
as gatekeepers of whose work can reach the scientific 
community. They have allowed only two percent participation 
in science from 80 percent of the world. And the numbers have 
become seriously worse during the last ten years.

ExtraMED, now in its second year, claims particular strength 
"in such topics as AIDS, tropical medicine, communicable 
diseases, emergency conditions, and traditional medicine." 
The database is distributed on CD-ROM, which stores the 
complete text of all pages of all articles as high-quality 
images -- together with a cumulative index which allows all 
disks to be searched with one command.

ExtraMED costs $1800 a year for 10 disks (50% less in the 
developing world). For more information, contact DV Trimmer, 
Informania Ltd., P.O. Box 1359, London W3 0ZU, England; fax 
011-44-1730-265398, email 100060.172@compuserve.com.


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