ORIGINAL

REMARKS \ 3 K
BY \S | Node
C, Everett Koop. M.D., Sc.D. |
SURGEON GENERAL
OF THE

U.S. PuBLic HEALTH SERVICE
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

PRESENTED TO THE SOCIETY OF STATESMEN/CHOWDER AND MARCHING CLUB
WASHINGTON, D.C,
June 15, 1988
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(GREETINGS TO HOSTS, GUESTS, FRIENDS, ETC.)

I,

IT,

TWO IMPORTANT COURT DECISIONS RECENTLY:

A.

B,

A JURY FOUND THE LIGGETT CIGARETTE COMPANY PARTLY
LIABLE FOR THE LUNG-CANCER DEATH OF ROSE CIPOLLONE,
SUPREME COURT UNANIMOUSLY RULED AGAINST THE FDA,
HOLDING IT LIABLE FOR INJURIES INCURRED BY PERSONS
RECEIVING FDA-IMPROVED VACCINES,

WHAT DO THEY MEAN?

TOBACCO CASE

A.

B,

C,

BOTH SIDES SAY THEY WON AND THE DECISION MAY BE
APPEALED. BuT THIS IS A SERIOUS SETBACK FOR THE
INDUSTRY} IT IS AN OPENING IN THEIR ARMOR AGAINST
LIABILITY SUITS,

We’LL SEE MANY MORE SUCH SUITS. IN FACT, THE LAWYERS
FOR THE CIPOLLONES HAVE 6 OTHER SMOKING CASES PENDING
IN NEw JERSEY COURTS AS IT IS,

IT 1S TIME FOR THE EXECUTIVE BRANCH AND THE CONGRESS TO
LOOK AT THE TOBACCO INDUSTRY ~~ THE GROWERS, THE
MANUFACTURERS, THE LABOR FORCE, AND SO ON -~ AND BEGIN
DEALING WITH THE INEVITABLE CHANGES TAKING PLACE, AS A
RESULT OF A FIRM BASE OF SCIENTIFIC EVIDENCE LINKING
CIGARETTES TO DISABILITY AND PREMATURE DEATH.
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IT IS NOT FAIR TO ALLOW THIS INDUSTRY -~ AND THE
THOUSANDS OF FAMILIES WHO RELY ON IT FOR INCOME -- TO
BE NIBBLED TO DEATH BY COURT DECISIONS OVER THE NEXT 10
YEARS. WE NEED TO BITE THE BULLET TODAY, JUST AS WE
DID WITH THE FIRST ANTI-CIGARETTE LEGISLATION IN 1966,
No QUESTION BUT THAT THE SURGEON GENERAL’S REPORTS OF
THE PAST 7 YEARS HAVE HURT THE INDUSTRY VERY BADLY,
THOSE REPORTS -- MANDATED BY THE CONGRESS -- ARE GOING
TO CONTINUE UNDER ME AND UNDER MY SUCCESSORS. THINGS
ARE JUST GOING TO GET WORSE, BOTH ON THE SCIENCE END
AND ON THE LIABILITY END,
IT’S TIME TO GET A SENSE OF THE WHOLE PICTURE AND TRY
TO HEAD OFF THE ECONOMIC AND SOCIAL CHAOS THAT WILL
SURELY HIT THOSE AREAS IN OUR COUNTRY WHERE TOBACCO IS
GROWN AND CIGARETTES ARE MANUFACTURED, THIS IS NOT A
REGIONAL ISSUE; IT’S A NATIONAL ISSUE.

II. VACCINE CASE

A.

HAVEN'T STUDIED THE COURT’S OPINION, BUT FROM WHAT I’VE
READ SO FAR, IT RAISES SERIOUS QUESTIONS ABOUT THE WAY
WE ESTIMATE RISKS AGAINST BENEFITS IN OUR SOCIETY, FROM
THE SCIENTIFIC PERSPECTIVE. BUT IT ALSO HIGHLIGHTS THE
PATCHWORK-QUILT WE HAVE OF LAWS GOVERNING DANGEROUS OR
POTENTIALLY SUBSTANCES IN THE MARKETPLACE,

We‘VE SET UP, BY LAW, A FUND TO PROTECT COMPANIES WHO
ARE SUED FOR A MISADVENTURE OCCURRING WITH A VACCINE
III, AIDS
A.

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THEY PRODUCED, SO WE RECOGNIZE THAT THERE IS NO SUCH
THING AS “ZERO RISK TOLERANCE,” ONCE A VACCINE GETS
INTO THE MARKETPLACE,
BuT, AS I UNDERSTAND IT, THIS VERDICT SEEMS TO SAY THAT
WE MUST BE ASSURED OF “ZERO RISK TOLERANCE” AT THE
POINT OF PRE-MARKETING APPROVAL, THAT’S KIND OF LIKE
THE “DELANEY CLAUSE” IN THE FDA LAW, WHICH REQUIRES
THAT THE FDA TAKE OFF THE MARKET ANYTHING THEY REGULATE
THAT MAY CAUSE CANCER,
BUT THE ENVIRONMENTAL PROTECTION AGENCY, THE DEPARTMENT
OF AGRICULTURE, AND THE NUCLEAR REGULATORY COMMISSION
HAVE NO “DELANEY CLAUSE” IN THEIR LAWS AND DO NOT
RECOGNIZE “ZERO RISK TOLERANCE” AS THE ONLY PERMISSIBLE
THRESHOLD TO CROSS ON THE WAY TO THE OPEN MARKET,
WE NEED TO ASK OURSELVES -- AS A HIGHLY INDUSTRIALIZED,
SCIENCE-BASED SOCIETY -~ HOW WE WANT TO MANAGE RISKS IN
ORDER TO OBTAIN THE BENEFITS OF SCIENCE AND INDUSTRY,

FINALLY, THE THIRD BIG ITEM OF NEWS THIS WEEK CAME OUT
OF STOCKHOLM, ALTHOUGH IT WAS REALLY NON-NEWS, ALL THE
HEADLINES [’VE SEEN SO FAR HAVE BEEN RE-RUNS OF STORIES
THAT HAVE BEEN REPORTED OVER THE 12 MONTHS SINCE THE
LAST INTERNATIONAL CONFERENCE WAS HELD HERE IN
WASHINGTON. DON’T MEAN TO MINIMIZE THE INFORMATION ...
JUST ITS SUDDEN APPEARANCE AND IMPACT,
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B. IN FACT, IN ONE SENSE, THERE IS A VERY IMPRESSIVE
STABILITY IN THE AIDS EPIDEMIC SO FAR.

THE MAJOR HIGH-RISK GROUPS 5, 6, AND 7 YEARS AGO ARE EXACTLY
THE SAME MAJOR HIGH-RISK GROUPS TODAY. FOR EXAMPLE, THE KEY
POPULATION GROUP WITH THE HIGHEST INFECTION AND DEATH RATES IS
COMPRISED OF HOMOSEXUALS AND BISEXUAL MALES. THE RISE IN NUMBERS
OF CASES IN THIS COUNTRY HAS BEEN PRIMARILY AMONG THIS GROUP,

IF ALL OF THEM WERE TO STOP ALL SEXUAL ACTIVITY TODAY ~~ OR
IF ALL WERE TO PRACTICE SAFER SEX BEHAVIOR AS OF TODAY -- THEN WE
MIGHT PREDICT THAT 2/5’S OF THE AMERICAN AIDS CASELOAD WOULD
BEGIN TO DISAPPEAR, BEGINNING AS SOON AS THIS SEPTEMBER,

SIMILARLY WITH INTRAVENOUS DRUG ABUSERS: IF THEY ALL STOPPED
SHARING NEEDLES TODAY, THEN 1/4 OF OUR CASELOAD WOULD BEGIN TO
DECLINE .+. AGAIN, BEGINNING AS EARLY AS SEPTEMBER,

AND SINCE DRUG ABUSERS ARE RESPONSIBLE FOR 3 OF EVERY 4
CHILDREN WITH AIDS, A CHANGE IN BEHAVIOR AMONG THEM WOULD
“DRASTICALLY REDUCE OUR PEDIATRIC AIDS CASELOAD AS WELL,

IN OTHER WORDS, BETTER THAN 90 PERCENT OF our AIDS CASES
TODAY ARE FROM THE SAME POPULATION AND BEHAVIOR GROUPS THAT
APPEARED VERY EARLY IN THE EPIDEMIC,
5.

THE WORRISOME POSSIBILITY THAT AIDS wouLD SPREAD LIKE
WILDFIRE AMONG THE GENERAL POPULATION HAS SO FAR NOT BECOME A
REALITY. HOWEVER, THE NUMBERS OF AIDS CASES INVOLVING
HETEROSEXUALS IS GOING UP -- AND QUICKLY -- SO IT’S HARD TO SAY
WHAT THESE NUMBERS WILL LOOK LIKE A FEW YEARS HENCE.

I'VE WARNED PEOPLE THAT THE EPIDEMIC HAS NOW HIT EVERY STATE
AND TERRITORY THAT IS A PART OF THE UNITED STATES, AND IT HAS,
BUT THE PATTERNS ARE STILL THE SAME:

* THE MAJORITY OF ALL NEW CASES OF AIDS REPORTED OVER THE PAST
12 MONTHS INVOLVED HOMOSEXUALS OR BISEXUAL MEN,

* THE NEXT LARGEST GROUP -- IV DRUG ABUSERS -~ ACCOUNT FOR
ABOUT ONE~FOURTH,

* AND HETEROSEXUAL CASES ACCOUNT FOR ONLY 4 PERCENT OF THE
TOTAL CASELOAD,

SO NOTHING MUCH HAS CHANGED.
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THE MAILING WE JUST DID TO EVERY HOUSEHOLD IN AMERICA MIGHT
BE CONSIDERED, THEREFORE, AN INSTRUMENT FOR EVEN FURTHER
STABILIZING THE SITUATION. THAT IS, KEEPING AIDS OUT OF THE
GENERAL POPULATION. IN OTHER WORDS, PEOPLE WHO DON’T ENGAGE IN
HIGH-RISK SEXUAL BEHAVIOR AND WHO DON’T “SHOOT” DRUGS. SHOULD STAY
THAT WAY,

THE HOMOSEXUAL COMMUNITY HAS BEEN SATURATED WITH THIS KIND
OF INFORMATION FOR THE PAST SEVERAL YEARS; I DOUBT THAT THE
HOUSE~TO-HOUSE MAILING CONTAINS ANYTHING THEY HAVEN’T YET SEEN OR
READ, AND WE CONCEDE THE FACT THAT THE MAILING PROBABLY ISN‘T
BEING READ BY PEOPLE WHO “SHOOT” DRUGS,

As WE'VE SAID MANY TIMES ~~ AND AS THEY'VE SAID ONCE AGAIN
IN STOCKHOLM -~ WE ARE MANY YEARS AWAY FROM A VACCINE, HENCE,
THE BEST AND ONLY WEAPON WE HAVE TO FIGHT AIDS IS EDUCATION vs,
EDUCATION ... AND MORE EDUCATION,