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        DEATH BY REGULATION -- THE PRICE WE PAY FOR THE FDA
                     By Dr. Mary J. Ruwart

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A MATTER OF LIFE AND DEATH
How would you feel if a member of your family had an incurable disease,
but they were forbidden, by law, to import a medicine which might save
them? If you think it can't happen here, think again. Until July of
1988, U.S. customs officials took dextran sulfate, a potential AIDS
therapy, away from the AIDS victims who had travelled all the way to
Japan to purchase it. By demonstrating how our Food and Drug laws are
killing thousands of innocent Americans, the AIDS community convinced
the Federal Food and Drug Administration (FDA) to allow limited
importation of medications from other countries for personal use. These
pharmaceuticals are not available here because of the "drug lag" our
laws have created.

In the United States, pharmaceutical firms are required to spend much
more time and money demonstrating that their drugs are safe and
effective. Afterwards, the FDA takes an average of two to six years to
decide whether the manufacturer will be allowed to market them.
Americans get new, life-saving drugs years later than citizens of other
countries that are not so restrictive. Some drugs which take a long time
to test, such as those that may retard aging, are not available to
Americans at all.

ABOUT THALIDOMIDE
Sometimes this delay protects us from drugs which have side effects
which are not readily predicted from animal studies. Thalidomide, for
example, was marketed in Europe for several years as a sedative while
awaiting approval for use in the United States. In the early 1960's, the
sensitivity of an unborn child to the deforming effects of drugs was not
widely appreciated, so doctors began prescribing thalidomide to pregnant
women. Consequently, approximately 12,000 European children were born
with deformed limbs. Few American babies were affected because only a
few test samples had been distributed in this country. The FDA physician
who had delayed its approval was given a Presidential Award.

PAYING WITH OUR LIVES
Encouraged by this feedback, the FDA began to require even more studies.
Testing and approval took even longer, especially when compared with
countries like Great Britain where there were no immediate changes in
the way new drugs were processed. While the British continued to enjoy
many new drugs to treat their illnesses, only half of these were
available to Americans, and only after many more years of waiting. One
of these new drugs denied to Americans was propranolol, the first
Beta-blocker to be used extensively to treat angina and hypertension.

Approximately 10,000 Americans died needlessly every year because it was
against the law for their doctors to treat them with propranolol.
Propranolol was finally approved here for minor uses in 1968, but was
only approved in 1973 and 1976 for angina and hypertension respectively.
The regulatory delay of this single drug may have been responsible for
the death of more Americans than all other deaths from drugs in this
century. Even so, the FDA came under severe criticism by Congress for
"premature" approval of this valuable drug! Former F.D.A. Commissioner
Alexander Schmidt noted that ". . . rarely, if ever, has Congress held
a hearing to look into the failure of F.D.A. to approve a new entity;
but it has held hundreds of hearings alleging that the F.D.A. has done
something wrong by approving a drug . . ."   The drug lag, he claimed,
could only "be remedied by Congressional and public recognition that
the failure to approve an important new drug can be as detrimental to
the public health as the approval of a potentially bad drug."

Just how detrimental is the drug lag to public health? Conservative
estimates of needless deaths due to the "drug lag" are tens, perhaps
hundreds of thousands of innocent Americans every year. Perhaps a loved
one youve lost was among them.

The saddest part of this story is that we gain very little by having a
"drug lag". Countries which have a faster approval process sometimes
withdraw a drug because it has side effects in humans that don't show up
in animal testing, but usually the number of deaths is less than the
number that die from aspirin each year. Aspirin causes malformations
when given to most pregnant animals, and could not gain FDA approval if
tested today.

While any harm from drugs is undesirable, we must recognize that no drug
is safe for everyone. People die every year from drug allergies or
idiosyncratic reactions which cannot be predicted with state-of-the-art
expertise. Whenever we take drugs, we must weigh the risks and the
potential benefits, just as we weigh the substantial risks and benefits
of driving an automobile. By demanding that the FDA protect us from
drugs that have any side effects, we deprive ourselves of drugs that
save hundreds of thousands of lives.

Ironically, FDA regulations sometimes force people to take more toxic
drugs. For example, one San Francisco physician encourages his AIDS
patients to take DDC, an unapproved drug, instead of DDI, a legal drug
that damages the pancreas. DDC is still in testing, but causes less
pancreatic damage than DDI, which eventually it will replace. Until
then, AIDS patients buy the safer substance from illegal buyers' clubs.
Sick people are forced to purchase their medicine on the black market
instead of from reputable pharmaceutical firms!

At least the AIDS patients can purchase DDC somewhere. Many of the
delays and extra testing demanded by the FDA often makes unpatentable
products, such as vitamin and mineral regimens, too expensive to
develop. Diseases that affect only a few are never researched, since the
development costs cannot be recovered. All these factors restrict the
areas in which we expand our knowledge. If common, everyday aspirin
cannot meet the rigorous standards of today's regulatory agencies, other
drugs, of equal or superior value, have undoubtedly been excluded from
our drugstore shelves too. As a former head of the FDA, Donald Kennedy,
noted, "the pattern of intervention into science from a combination of
local, state, and federal sources has moved from reasonable control to
something close to chaotic strangulation."

THE EASY WAY OUT
What do we do when even those affiliated with the FDA can see that drug
regulation flunks its own criteria of being safe and effective? How do
we stop our tax dollars from being spent on killing both ourselves and
our loved ones? How do we insure that Americans get all the safe and
effective drugs possible?

Patients and their physicians legally should be able to buy whatever
drugs they wish, regardless of the stage of testing. Each person needs
to decide for themselves, in consultation with their physician or other
specialists, which risks they are willing to take. Those who wish to
wait for FDA approval or a "Seal of Approval" from a medical
organization or a consumers group will have that option. Those who, like
AIDS patients, can't wait a decade or two for a new drug to be tested
and approved, should be able to buy pharmaceuticals direct from the
manufacturer -- either here or abroad. Sometimes people may feel it's
worth the risk to try something experimental or not fully tested for
safety. It is their life, and it should be their choice. If your loved
ones were dying, wouldn't you want access to every possible chance?

WE'VE DONE IT BEFORE
In the early 1900's, Americans could decide for themselves which drugs
to take. Before the FDA came into being, American drug manufacturers
usually gave their customers the best drugs that the state-of-the-art
would allow. After all, killing the customer is bad business. Deaths due
to inadequate testing were much less frequent than the deaths produced
by todays ``drug lag. In evaluating our FDA regulations, Professor
Peltzman at the University of Chicago concluded that "the penalties
imposed by the marketplace on sellers of ineffective drugs before 1962 .
. . have left little room for improvement by a regulatory agency." It
is time to quit asking the impossible from the FDA. It's time to stop
denying ourselves and our loved ones life-saving drugs.

Dr. Mary Ruwart is a Senior Research Scientist for the Upjohn Co. in
Kalamazoo, Michigan. Cited in "Who's Who of American Women" in 1989 and
1990 and in "American Men and Women of Science", she is the author
of over 50 scientific publications and is intimately involved on a daily
basis in pharmaceutical research and development.


                       RECOMMENDED READING

The Regulated Consumer (Mary B. Peterson) ....................  $2.95
(With introduction by Milton Friedman)
Life Extension (Durk Pearson & Sandy Shaw .................... $14.95
(Includes review on F.D.A.)
Healing Our World (Dr. Mary Ruwart) .......................... $14.95


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