Congressional hearings try to diagnose why 'miracle' drug RU-486 is not available


November 25, 1990|By LYLE DENNISTON

Somewhere, in this country or overseas, there is supposed to be a villain who can be blamed for creating the almost unsolvable legal puzzle over use of the next "miracle" drug: RU-486. But everyone who might be the culprit is pointing at someone else.

RU-486 -- a drug invented in France a decade ago -- is now proclaimed by many doctors, researchers, scientists and victims some kinds of cancer as a "medical breakthrough," a truly revolutionary new medicine. Depending upon what future tests show, RU-486 might even be useful in dealing with the AIDS epidemic. It also has a wide potential for use in dealing with women's fertility.

But the drug can't be used in this country for routine medical treatment, even for those diseases for which it has proved most effective: breast cancer and the sometimes fatal cortisone-excess disorder known as Cushing's syndrome.

Legally speaking, RU-486 can be used here only in a few, quite narrow clinical experiments. And talk of bringing it in through a "black market" or smuggling operation is, apparently, just talk, so far. The U.S. Food and Drug Administration has no reports of any illegal imports of the drug.

So, who's to blame for keeping it mostly out of this country?

No matter who is blameworthy, there is a basic explanation for its general unavailability here: It is at the center of a nearly global controversy because it is, in fact, best known around the world as an "anti-abortion pill."

It is a drug that can make it far easier (and far more private) to have abortions early in pregnancy -- without surgery. Like anything else that is touched by the abortion controversy, RU-486 is caught between very powerful and so far unrelenting forces: emotional, political, moral, social, economic. Those forces have all been caught up in the legal tangle surrounding RU-486.

RU-486 is not illegal in the United States for all purposes, but few lawful uses are available. It is against the law right now to import the drug for personal use, to use it to cause an abortion, to do any kind of research or experimentation on it without first getting a drug-investigation permit from the FDA or to manufacture or market it here (because the FDA has not cleared it for that).

Someone, it is commonly suggested, is responsible for the plight of RU-486 and the plight of those who want to test it, give it or take it, and thus someone supposedly should be able to fix that.

A member of Congress, Representative Ron Wyden, D-Ore., held a hearing here last week to press that suggestion with renewed vigor.

For more than three hours, he tried his best to put the blame on the FDA and on anti-abortion members of Congress who have kept up the pressure on the FDA to see that RU-486 does not come to the United States.

The FDA, however, was having none of that and stubbornly argued that it was only enforcing a law enacted by Congress, the law that says unapproved drugs are not to be let into this country. Defiantly, FDA general counsel Sandra Barnes told Mr. Wyden that "Congress has not seen fit to change" existing law -- a statement that, in the hearing room, sounded very close to a dare.

(Congress, it could be noted, technically has it within its power to revise the law to assure that RU-486 is imported, but there appears to be no way -- politically -- that such a change could get passed. Even if it did get through Congress, President Bush in all probability would veto it.)

But the list of those responsible for the prevailing situation with RU-486 does not end with Congress, with the FDA or with the Bush White House. Consider some of the other actors in the continuing saga:

* The French manufacturer of RU-486, Roussel Uclaf. The FDA says that the company is the one that is holding back the drug from the United States; an FDA official told Representative Wyden that one potential testing organization was given FDA permission to bring in RU-486, but that its request for a supply was rejected by Roussel Uclaf.

* The French manufacturer's U.S. subsidiary. It has declared that it has no interest in applying for FDA approval of RU-486 -- apparently out of fear of a boycott of all of its products, promised by anti-abortion forces.

* Other U.S. pharmaceutical firms. They, too, have not been lining up to ask the FDA to let them market the drug here because they, too, fear the threatened boycott of everything else they make and sell.

* The French manufacturer's German parent firm, Hoechst AG. It has shown little interest in having the drug marketed or used anywhere -- even in France, where the government forced the subsidiary there to keep the drug available and in use.

* The patients with diseases that could be treated with the drug, and the patients' rights organizations that are promoting its use here. Some research scientists complain that the patients' lobby is doing just as much as anti-abortion forces to keep the fight over RU-486 stirred up.

* Activists on both sides of the abortion controversy, who keep up the political and other forms of pressure they think will help them get their way ultimately on RU-486.

* The American Medical Association, which simultaneously finds itself able to support the FDA's import restrictions even as it supports the idea of more research on the drug -- even for possible use for abortion.

With that many competing interests at stake, it was small wonder that, at the close of last week's congressional hearing, Mr. Wyden was still asking the same basic question his staff had posed as the reason for calling the hearing: Who in government is going to become the advocate for RU-486 and "turn this situation around"? His hearing provided no answer -- except possibly the answer that, for the time being at least, the political risks are too big to try to untie the legal knots around RU-486.

Lyle Denniston is The Sun's legal correspondent in Washington and makes his base at the Supreme Court.

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