[net.med] DTP vaccine risks

kenc@islenet.UUCP (Ken Cribbs) (09/24/85)

     I agree that it's foolish and dangerous to withhold DTP
 immunizations from small children; the "D" (diptheria) and "T"
 (tetanus) portions, at least, are remarkably safe products, and
 pertussis (whooping cough) can be a devastating disease in
 infants.  But that doesn't mean we should continue to tolerate a
 substandard pertussis ("P") vaccine when the technology exists to
 make a MUCH safer product!

     To paraphrase and expand upon my recent net.med posting
 (#1265):

     American pertussis vaccines are crude, outdated whole-cell
 biologicals which could and should have been improved years ago.
 At present the documented statistical risk of serious adverse
 reactions from the pertussis component of a DTP immunization
 (i.e., seizure disorder, mental retardation, death) is less than
 the statistical risk of the disease itself in an unimmunized
 population; but this small immunization risk can be virtually
 eliminated by applying present-day technology to the vaccine
 manufacturing process.  (By the way, it's only a "small" risk
 from a statistical/epidemiological viewpoint.  Those few children
 who develop post-pertussis-vaccination encephalopathy are
 severely handicapped for life.)

     Parents and health care professionals should be aware that a
 safe "acellular" vaccine is available in Japan, where it has been
 in general use since around 1981 with no reports of serious
 neurological complications after more than 15 million
 immunizations.  The Japanese DTP immunization is manufactured
 using relatively current technologies of vaccine production,
 similar to the methods American manufacturers use to make their
 newer bacterial vaccines (such as that for Hemophilus
 influenzae).  But American-made DTP vaccines haven't benefitted
 from these state-of-the-art technologies; rather, they're still
 whole-cell preparations, essentially the same as they were 35
 and 40 years ago when immunology and microbiology were
 unsophisticated sciences.  These antiquated pertussis vaccines
 are inherently difficult to standardize, so there is an amazing
 lot-to-lot variation in their potency and reactogenicity.
 They're laden with endotoxins and other substances that probably
 aren't necessary in order to induce an adequate antibody response
 in the vaccine recipient.

     The most conservative American statistics show that at least
 1 in 310,000 children immunized with American DTP vaccine will
 suffer serious, disabling neurologic sequelae from its pertussis
 component.  After reviewing hundreds of case files, I personally
 believe the incidence of major adverse reactions is much higher;
 but, whatever the true figure, we would probably see greater
 morbidity and mortality from widespread outbreaks of clinical
 pertussis than from continued use of the present vaccine.
 Pertussis is a deadly disease, and I agree that infants should
 be immunized against it whenever possible.  But at the same time,
 I insist that American vaccine manufacturers must use the very
 best technologies available to them to make a safer vaccine.
 After all, the Japanese have succeeded in making and marketing a
 safe, effective product, and they're using techniques first
 developed in the United States 20 years ago.

     Almost every state requires schoolchildren to be immunized
 against pertussis.  From a public policy standpoint, I can't
 argue with the wisdom of those requirements; but at the same
 time, mandatory immunization laws have created a captive market
 for American vaccine manufacturers, and so have eliminated the
 economic incentives for new product improvement.  Why should they
 spend money on improving a product that every child must receive,
 like it or not?

     The direct economic costs of raising and caring for even a
 few of the victims of our dirty American vaccine would easily
 outweigh the expense of research and development to upgrade
 vaccine technology and production facilities.  Unfortunately, the
 DTP controversy has been caught up in the growing ideological
 battle between the legal and medical professions.  Many otherwise
 well-meaning scientists have lost their objectivity in the face
 of a perceived "attack" by attorneys who represent the infant
 victims of the vaccine.  But so long as this avoidably hazardous
 vaccine remains on the market (and it will, since it is mandated
 by our state governments), the parents of those tragic children
 will continue to pursue its manufacturers in the court system.
 To do otherwise would be to reward economic opportunism at the
 expense of moral responsibility.

                                   -- Ken Cribbs
                                  {ihnp4,dual,vortex}!islenet!kenc