Subject: (Editorial):  Flying Happiness Pharmaceuticals
Date: Published: 7/26/88 99 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

   REVIEW & OUTLOOK (Editorial):  
   Flying Happiness Pharmaceuticals

   The U. S. system of drug regulation hit the wall Saturday.
The man seen walking away from the wreckage was Food and Drug
Administration Commissioner Frank Young.
   Dr. Young went before a hostile audience of AIDS patients
in Boston to announce that the FDA last Wednesday informed
its regional offices to begin allowing people with AIDS to
import from foreign countries drugs unapproved for sale in
the U. S. The agency will allow an order to include only
enough drugs to provide about three months of treatment; this
will prevent "commercial" quantities from being imported.
   In one sense, the announcement's a breakthrough for AIDS
patients.  In another, it's a bureaucratic core meltdown.  What
Dr. Young's announcement means, after all, is that AIDS
patients will still need FDA approval before buying any drug
from, say, Merck or Lilly.  But they can buy anything they
want from Flying Happiness Pharmaceuticals of Taipei or
Drogas de Baja Tijuana, S. A. 
   Something here is backward.
   The FDA announcement officially recognizes a truth known
for years to this country's sickest people:  If you're rich
enough or aggressive enough, you can find hopeful drugs in
other countries that aren't available here.  It will of course
be a good thing if this latest proposal actually gives
respite to some victims of AIDS, Alzheimer's disease, cancer
or other intractable diseases, who apparently will also get
the benefit of mail-order drugs.  But everyone should
understand clearly the implications of Dr. Young's speech in
Boston.
   Under this "nonprofit" mail-order drug business, U. S. AIDS
patients will scour the medical literature of Asia, Europe
and Latin America for news of promising therapies instead of
looking to the huge U. S. pharmaceutical industry and academic
community for help.  Gray-market drug houses overseas will
surely try to produce knockoffs of chemical entities
developed by firms or academic centers with serious R&D
commitments.
   These columns have campaigned for a drug-approval system
that would make available to desperately ill people drugs
that hold some promise of delivering them from their
suffering.  We find Dr. Young's blessing of a system that
bootlegs drugs up from places like Tijuana ironic, insofar as
he was on these pages only 12 days ago denouncing our
proposal that the government suspend the Kefauver amendments
during the AIDS crisis.
    Mandated since 1962, the Kefauver rule mandates efficacy,
which is to say it's primarily responsible for the thick
tangle of protocols, approval committees, steering
committees, advisory committees and reconfirmation studies
that now enwraps the American drug-development system.
   "In the guise of giving the dying 'hope,' your editorial
would undercut the science that can lead to a true and useful
therapy," Dr. Young wrote of our plan to suspend the efficacy
requirement while retaining safety approval.  Ten days later,
Commissioner Young ran up the white flag on efficacy, safety,
quality control and all.  Faced with AIDS patients bootlegging
drugs into the U. S. from Mexico and the Far East, he told his
Boston audience, "I'm not going to be the commissioner that
robs them of hope."
   This development marks the intersection of two colliding
realities.  The first is that in AIDS the United States has a
huge and expanding health crisis.  The second is that the
 American drug development process has become so encumbered
with restrictions and red tape that it can no longer respond
efficiently to this or any other human crisis.
   In response, Congress holds hearings to rail against NIH
officials who have little power to make an entrenched system
move faster.  The President's AIDS Commission describes in
detail the FDA's red-tape problems.  But no one -- not the
President, not HHS Secretary Bowen, not such congressional
FDA-bashers as Henry Waxman or Ted Weiss, not the U. S. 
medical community, and certainly not the FDA's careerists -- 
is inclined to alter the status quo.
   After Dr. Young's announcement, Massachusetts Congressman
Barney Frank commented, "We would have more money for health
issues if it weren't for increased defense spending."  Rep. 
Gerry Studds added, "This President seems to think the answer
to this disease is monogamy and marriage."  In other words,
these two have nothing very useful to contribute.  The status
quo prevails; the political establishment continues to play
games with AIDS victims.
   If Messrs. Frank and Studds wanted to act rather than
talk, they'd use their position to introduce a bill relieving
the anti-AIDS effort of Kefauver's enormous burden.  Till
then, people with AIDS will have to search for help in the
 old familiar places the FDA has just "approved" -- foreign
drug stores.

[This article is made available here by Dow Jones Co. for the 
personal and non-commercial use of callers to this bbs, in the 
hope that it will be of some help to those who are suffering 
from the disease and others who are seeking to help them.]