798

hearings before the CPMP reaches an

opinion. States may refer to the CPMP foran opinion when there is no consensus onwhat action to take over an issue of drugsafety. The CPMP’s opinions are, how-ever, not binding, and states tend to takenational action before communicating withthe CPMP or other states. :

In the future system pharmacovigilancewill still remain a national activity, to becoordinated by the EMEA, but there willbe specific objectives concerning the col-lection and speed of transmission of datathat states and pharmaceutical companieshave to meet. Furthermore, the CPMP’sopinions will be binding. To facilitate

communication computer systems used bymember states are being reviewed; a pilotelectronic network (the European NervousSystem) for transmitting information be-tween the UK, Spain, and France will beextended to the other states and the Com-

mission ; and tenders will soon be put outfor a feasibility study on an electronicnetwork for the regulation system andrelevant databases. In addition, a EuropeanPharmacovigilance Research Group hasbeen set up to examine existing methods ofpostmarketing surveillance; to learn aboutand improve patterns of reporting of ad-verse reactions; to investigate the potentialof, and undertake, transnational case-

control and cohort studies; and to developguidelines for postmarketing surveillance. :A likely hurdle that several speakers

drew attention to will be the achievement ofconsensus, a difficulty that carries legal

MEDWatch

: In June the US Food and Drug Admin- :: istration introduced MEDWatch, its

: postmarketing surveillance system that replaced several existing ones (seeLancet June 5, p 1465). Nearly 11 000 :MEDWatch reports have been re- :ceived. About 75% of these have beensent to the agency’s Center for Drugsfor follow up, about 15% to the Center for Devices, and the rest to sectionssuch as biologicals or foods. More than :50% of the reports were made by :pharmacists, another 25% doctors andnurses, and most of the rest by patients.

implications should issues of productliability arise in a country whose views wereoverruled by the final CPMP decision. Thecurrent view is that EMEA will be liable forCPMP decisions and the member stateswill be subject to vicarious liability. :

Suggestions for improving pharmacovi-gilance globally included the adoption of aninternational birthday for drugs; everydrug would thus have an annual drug safetyupdate on a fixed date. Another proposalwas for the third round of InternationalCommittee on Harmonisation activities

(after the second ICH conference in

Orlando, Florida, USA, next month) toinclude pharmacovigilance issues.

Vivien Choo

25 years of spontaneous ADR reportingThis week the WHO and CIOMS celebrated in Geneva the 25th anniversary of a voluntaryreporting system for adverse drug reactions. The two organisations cooperate in providingguidelines on pharmacovigilance. Data from the reporting system are stored in a hugedatabank in Uppsala, Sweden. What has been the value of the efforts of the twoorganisations to their clients? Those running the bank at Uppsala would like the data heldthere to be more widely used by scientists. The pharmaceutical industry, however, seems tobe satisfied with the guidance they get from CIOMS.One way of assessing the value of the system is to find out whether the "signals" from the

reporting system have led to confirmation by epidemiological studies and eventually towarnings or advice to doctors. Rarely has this been the case because, unlike efficacy studies,adverse reaction studies attract few sponsors. Journal reports remain the mainstay of sourceof information on adverse reactions for the prescriber. Yet highly motivated doctors whosend information to adverse-reaction reporting systems deserve some feedback. But thebanks have not had the resources to provide such a service. For example, it took many yearsbefore the bank at Uppsala had a medical director. In many cases, what doctors need itsinstant feedback. The French system of regional centres that provide an advisory service onadverse drug reactions is a good model, though not necessarily the only one. :

Karl H Kimbel

Adverse events andchildhood vaccines

The US National Academy of Science’sInstitute of Medicine report! on adverseevents associated with US-licensed vac-cines for tetanus, diphtheria, measles,mumps, polio, Haemophilus influenzae typeB, and hepatitis B is the second of two

requested by the US Congress in the 1985National Childhood Vaccine Injury Act,which established a compensation pro-gramme for persons who may have been

injured by vaccines. The first report, in1991, looked at adverse consequences ofpertussis and rubella vaccines.

In the second report the committeeconcluded that the evidence establishes acausal relation between:* Diphtheria and tetanus toxoids and

anaphylaxis* Measles vaccine and death from measles-vaccine-strain infection.* Measles-mumps-rubella vaccine and

thrombocytopenia and anaphylaxis. Oral poliovaccine and poliomyelitis anddeath from poliovaccine-strain infection* Hepatitis B vaccine and anaphylaxis.The committee said the evidence favours

acceptance of a causal relation between:* Diphtheria and tetanus toxoids andGuillain-Barre syndrome and brachialneuritis

w Measles vaccine and anaphylaxisw Oral poliovaccine and Guillain-Barre

syndrome* Unconjugated (polyribosylribitol, PRP)Hib vaccine and early onset Hib disease (inchildren 318 months whose first Hibimmunisation is PRP).The committee found that the evidence

favoured rejection of causal relations be-tween : diphtheria and tetanus toxoids andencephalopathy, infantile spasms, anddeath from sudden infant death syndrome;and conjugated Hib vaccines and early-onset Hib disease.For other adverse events associated with

these vaccines, such as those reportedbetween measles vaccines and cases of

subacute sclerosing panencephalitis, thecommittee found that the evidence was not

strong enough for acceptance or rejection ofa causal relation.

Michael McCarthy

1 Institute of Medicine. Adverse eventsassociated with childhood vaccines: evidencebearing on causality. Washington: NationalAcademy Press, 1993.

UNESCO and bioethics

The 50-strong International Committee onBioethics set up by UNESCO held its firstmeeting at the organisation’s headquartersin Paris on Sept 15 and 16. The committeeis presided over by Noelle Lenoir, a mem-ber of UNESCO’s constitutional council.

They have been preparing reports on theprogress of the Human Genome Project,and on ethical issues related to geneticdiagnosis and screening, gene therapy,access to data, responsibility of scientists,and the relation between population gene-tics, national development, and demogra-phy. The conclusions reached last week willbe presented at the next UNESCO general

convention. One of the committee’s maintasks is to prepare international recom-mendations for the "protection" of thehuman genome. Another task is to helpdisseminate knowledge on genetics to thenon-commercial sector, universities, anddeveloping countries.

Jean-Michel Bader