Subject: Isoprinosine by Mail
Date: Jul  4 1986 (214 lines)

&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
J O H N   J A M E S  writes  on  A I D S
&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&

Copyright 1986 by John S. James;
permission granted for non-commercial use.

Issue Number 7, July 4, 1986


ISOPRINOSINE BY MAIL

Update 1989:  The Hauptmann Institute is no longer in business.

        Many persons with AIDS or ARC have had to travel abroad
for treatments which are probably helpful but have not been
approveed for marketing in this country.  The most common of such
treatments are ribavirin and isoprinosine, which have been
approved in dozens of countries and are often sold over the
counter in pharmacies.  At this time, Americans are usually
allowed to bring in about one month's personal supply of these
pharmaceuticals from Mexico.  (To find out more about doing so,
call Project Inform).

        The problem, of course, is the expense and stress of
repeated trips to Mexico, especially the continued uncertainty
about what will happen at the border.  Also, many people who need
these medicines are too ill to travel, and it is illegal for
anyone else to bring in a supply for them.  That's why we were
interested to learn that at least one company sells unapproved
drugs to Americans by mail from abroad, and has been doing so for
at least two years, and currently does sell isoprinosine.

        Apparently the key legal fact which makes this business
possible is that the sellers are foreign nationals operating
outside of the U.S., and therefore they are not subject to the
jurisdiction of U.S. laws.  U.S. Customs cannot afford to unwrap
every package which comes in, so they use spot checks instead.
Some of the shipments are seized and destroyed, resulting in loss
of what the buyer paid; but the seller has had some time to
develop expertise in how to ship packages so that most of them
get through.  Customs has more important priorities, such as
narcotics, which come under entirely different laws; stopping
small amounts of medicines ordered for personal use to save
someone's life is a lower priority for them.

        Conceivably the buyer could be charged with "conspiracy"
with the foreign suppliers to cause international shipment of the
unapproved pharmaceuticals -- but we have never heard of such a
case and consider it very unlikely, providing that the quantities
involved are intended only for personal use.  Prosecuting a
person with AIDS or ARC for this reason would make the government
look bad.  And the prosecutor would have to prove that you had
placed the order -- hard to do if reasonable precautions were
taken such as paying anonymously by money order, and refusing to
discuss the matter with any official or investigator, in the
unlikely event that anyone inquired.  Usually, if a shipment does
get seized, Customs will merely write to the addressee, giving
him or her the choice of forfeiting the material or appearing in
court to contest the seizure.  People usually have it forfeited
if this occurs.          So far, this writer knows of only one
company which sells isoprinosine by mail to U.S. customers:
(Reference to the Hauptmann Institute deleted by editor; this
Institute is no longer operating.)  Unfortunately, the price is
$148 for a bottle of 100 500-mg tablets.  This is over ten times
the current price in Mexico ($2.47 for a box of 20).
Incidentally, The Hauptmann Institute also sells other unapproved
drugs, unrelated to AIDS, which are not overpriced; they cost
about the same as if purchased in Mexico.  (Editors note:
references to the Hauptmann Institute and this discussion of
prices are reprinted here for historical purposes; the Institute
is not in operation.)  At this price, few will want to buy by
mail -- especially since the Hauptmann Institute does not sell
ribavirin also, so those who want to use both will still have to
make the trips abroad.  But what's important is that such a
business can operate, as this one has for some time.  If it
becomes well known that companies can sell by mail into the U.S.,
and that there is a demand, then others will follow.  Many people
would pay a reasonable markup to avoid repeated trips abroad; so
a small business might even fill orders through retail purchases
off pharmacy shelves, avoiding the need to finance and maintain
an inventory.

        Anyone considering using unapproved drugs should note
several points:

        (1)  Get the advice of your physician.  But if you ask
"Should I use (an unapproved drug)", the physician has to say no.
Instead, if you say that you plan to do it, then an informed and
sympathetic physician can discuss the pros and cons, offer advice
on how to do so safely, or why you should not do it at all.

        (2)  Watch out for fraudulent operations, such as
counterfeit pills or companies which just take the money.  We can
expect to see profiteering and other rip-offs, and it will be
hard to stop them by legal action.  But we do have control in
that most of the sales will depend on repeat customers -- who are
organized and talking to each other.  We may need to find labs to
analyze samples and make sure the products are legitimate.  Any
company in business for the long haul will have lots of incentive
to build and preserve its reputation, its most valuable asset.

        (3)  To help guard against counterfeits, and also to
prevent chemical deterioration, customers should expect medicines
to be sealed in their original containers by the manufacturer.
In one case we heard about, isoprinosine tablets became
discolored after being removed from their individual sealed
wrappers and exposed to air for two months.

        (4)  Ultimately we should insist that beneficial or
necessary drugs be available legally in an emergency.  The
problem isn't anything wrong with these medicines, but that all
new prescription drugs must go through a separate U.S. approval
process which takes years and costs tens of millions of dollars.
This procedure might make sense for pharmaceuticals intended for
mass marketing, when alternatives are available; but in an
emergency, people should have more freedom to make in informed
choice and weigh risks and benefits for themselves.

        In current practice, decision making first reflects the
interests of the most powerful -- major corporations and Federal
regulatory bureaucracies.  Only after their demands have been met
are the needs of patients considered.  It is unconscionable to
continue locking medical decisions into this straitjacket of
institutional convenience.

COMPASSION IN RESEARCH?

        Last week, at the international AIDS conference in Paris,
an associate professor at the Harvard Medical School presented
results of a study of ribavirin.  This study gave it to 15
persons with AIDS or ARC, and reported good results and no
toxicity from the drug after eight weeks.  But when the treatment
was stopped, the virus returned.

        This is the same ribavirin which people have been taking
for months on their own, if they can keep making trips to Mexico
to bring back the permitted one-month personal supply (to find
out more about doing so, contact Project Inform).  (If someone is
too ill to travel, it is illegal for anyone else to bring in
their supply for them.)  It is the same ribavirin which has been
approved as an antiviral in dozens of countries around the world.

        Then why, in the middle of an epidemic, isn't it allowed
here?  The main reason seems to be that if the government made an
exception to the lengthy approval process, due to the AIDS
emergency, then other companies would complain that their
products didn't get an exception, too.

        If it has taken until now for officially-sanctioned
researchers to publish a trial with fifteen patients, imagine how
long it takes for the complete approval process -- even for a
medicine already known to be beneficial.

        Another problem is that the manufacturer, which has a
legal monopoly on ribavirin, recently imposed a major price
increase even though the drug was already expensive and a serious
financial burden to its users.  Insurance will not pay for
ribavirin because it is not officially approved.

        Federal new-drug approvals, intended to protect the
public from unsafe or ineffective drugs, have in fact become
chips in a corporate bartering process.  They impact stock
prices, determine the fate of investments, and set the ground
rules for an institutional game of inside tracks and old-boy
networks.  The patients are not represented.

        Why are you and your doctor not allowed to consider
ribavirin, which is quite safe, well known, well tested, and in
use in dozens of other countries?  Not for your good, but rather
because the manufacturer has not yet earned the right to market
it in the U.S.  Therefore no one can sell or provide it here,
aside from limited and restricted experimental trials, even when
persons with AIDS or ARC could clearly benefit by having the
option.

        Why are you and your doctor not allowed to weigh the
risks and benefits of azidothymidine, which is more dangerous
than ribavirin but also more effective?  Why not AL 721, almost
certainly completely safe, although we do not know how effective
because trials were delayed for months and began just recently,
on only eleven patients, and in secrecy?  Why are persons with
AIDS or ARC told to wait a year or more, for definitive results
on treatments already known with fair-to-high confidence to offer
important benefit?

        A special legal status called "compassionate use"
approval is supposed to provide an emergency exception to such
roadblocks.  But a drug company must apply for compassionate use,
and the U.S. Food and Drug Administration must grant approval.
The process includes lots of red tape, and considerable expense
to the company.  We are hearing that there is less interest in
compassionate use for AIDS or ARC than for other diseases which
affect far fewer people.  Once again we see that the institutions
of this country are refusing to respond to AIDS as an emergency.

        Repeated appeals to change these hideous policies have
had little success.  Perhaps we need to let more people know
exactly what is happening, how business decisions and government
regulations are delaying the most promising research, and
prohibiting doctors from using what is here now to save lives.
Perhaps we will need lawsuits by the friends and families of
those denied access to the best treatments available.  Certainly
we need to develop our own understanding of the situation, and
our own channels for getting things done.

Obsolete subscription information has been removed.  See the
latest issues for up-to-date information. -- sysop]

&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&&
           End of display