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.