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LIVE POLIO IRUS VACCINES

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462<br />

Discussion<br />

one was sponsored by the local medical society<br />

and one by the Junior Chamber of Commerce.<br />

The tricounty medical society of the three rural<br />

counties also asked to be included. Studies in<br />

the three large cities were developed after we had<br />

received assurances of active cooperation of the<br />

health officer, the school authorities, and the<br />

medical societies concerned. Subsequently, we<br />

have had any number of requests for inclusion<br />

in the study.<br />

The Minneapolis Tribune, which has a poll<br />

service for determining state-wide public opinion<br />

on subjects of public interest, reported on 26<br />

May 1960 that 79 per cent of the people in Minnesota<br />

knew about the Minnesota feeding experiments,<br />

which included a placebo. Approximately<br />

75 per cent of the people said that they would<br />

be willing to take part in such an experiment<br />

if given the opportunity. I believe this gives you<br />

some idea of the public confidence in the oral<br />

vaccine studies in Minnesota.<br />

The Minnesota State Board of Health is an<br />

administrative board of health. It has had,<br />

throughout this whole polio experience described<br />

to you, an advisory committee on poliomyelitis,<br />

both for the Salk vaccine programs and for the<br />

oral vaccine studies. The Board specifically<br />

said that it felt it had a responsibility of doing<br />

everything it could in the evaluation of this oral<br />

vaccine.<br />

This is one of the reasons why Minnesota has<br />

been involved in the study of the use of oral<br />

vaccine for such a long period of time. We are<br />

convinced, of course, that the vaccine is safe and<br />

that it is effective.<br />

May I add that this study has been headed for<br />

the entire period by Dr. Bauer, whom you heard<br />

earlier.<br />

I can only say that we feel, of course, very<br />

pleased. We have had no problems with the<br />

vaccine. We have maintained a very close surveillance.<br />

We approached the Surgeon General<br />

with the request that he assign observers to these<br />

feeding experiments, and we specifically requested<br />

that Dr. Carl Eklund be assigned as an<br />

observer to Minnesota. Since he spent a considerable<br />

amount of time interviewing families<br />

who participated in the study, 1 should like to<br />

have him recognized at this time.<br />

DR. EKLUND: 1 feel very strongly that studies<br />

like this should be set up in a double-blind manner<br />

and planned in such a way as to produce<br />

answers.<br />

In Minnesota there were nine areas, and no<br />

one outside of these areas could take any oral<br />

vaccine. We therefore had a chance to study<br />

spread from vaccinated groups to unvaccinated<br />

groups. Within the areas, the study was completely<br />

double blind, so it was possible to interview<br />

people without knowing whether they liad<br />

taken vaccine or placebo.<br />

My main concern has been to see whether any<br />

ill effects come from this vaccine. I went from<br />

family to family and interviewed people without<br />

knowing what they had taken. I interviewed<br />

physicians. I went to small rural schools. 1<br />

could not tell a placebo lot from a vaccine group.<br />

All I knew was the lot numbers.<br />

No illness accumulated in any lot number.<br />

Complaints would vary from one area to another,<br />

but there was no uniformity in complaints and<br />

no serious ones of any kind.<br />

One saw miscellaneous diseases in the community-skin<br />

rashes, mumps, measles, chickenpox,<br />

broken legs, operations, tonsillectomies, etc.<br />

But to date, there has been no evidence of any<br />

ill effect.<br />

I believe that future studies should be set<br />

up in this manner so as to avoid obtaining controversial<br />

data.<br />

DR. BODIAN: Since Dr. Eklund has done a<br />

most remarkable single-handed job of case finding,<br />

I should like to inquire whether he also<br />

asked the people who had received placebo and<br />

vaccine, first, whether they had previously had<br />

Salk vaccine; second, how many of those interviewed<br />

might have been in the age group that<br />

Sir MacFarlane Burnet mentioned; and third,<br />

whether they were triple or double negatives.<br />

DR. EKLUND: I think the points raised are very<br />

pertinent. First, you have to collect fecal specimens<br />

in every area to know what viruses are circulating<br />

before your study starts; second, you<br />

have to bleed part of the population; and third,<br />

you have to know the Salk status. All three of<br />

these steps were taken.

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