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DLRM CALLS FOR A JUDICIAL INQUIRY INTO THE QUESTIONABLE VALIDITY
OF ANIMAL EXPERIMENTS FOR PREDICTING ADVERSE DRUG REACTIONS
Characterizing reliance upon testing drugs intended for humans on other species as "the greatest blunder in medical history," Doctor Andre Menache, president of London-based Doctors and Lawyers for Responsible Medicine, has asked the UK Home Secretary Jack Straw for a judicial enquiry into animal experimentation for medical research.
In a letter (7 Jan 2000) signed also by DLRM vice president Michael Mansfield, QC, and co-founder Joy Palmer, he pointed out that "the results of animal experiments cannot be extrapolated to humans with any degree of confidence." The letter went on to quote from a statement by Prof. Gerhard Zbinden, former chief consultant to the World Health Organization: "Most adverse (drug) reactions (ADR's) which occur in man cannot be demonstrated, anticipated or avoided by the routine subacute and chronic (animal) toxicity experiment." (Applied Therapeutics, 1966, 8, pp 128-133)
The letter also cited a British Medical Journal (v. 316, 25-4-98) report that ADV's account for 5% of UK hospital admissions and occur in 10-20% of hospital patients "resulting in loss of life or a lessening of the quality of life".
A reply received from Parliamentary Under Secretary of State Mike O'Brien stated: "It is wrong to single out animal tests for criticism when some products cause unexpected problems." It also disclosed that he did not believe an enquiry would be cost effective and that the Animal Procedures Committee would be considering the "validity of using animals in science" later this year. In other words: no changes are likely.
DLRM responded, 29 Feb 2000, with additional information including corroborating American figures ranking ADRs as "at least sixth leading cause of death in the United States" after heart disease, cancer, lung disease, strokes and accidents and as high as fourth in the opinion of some scientists. All seem to agree that ADRs are underreported, however.
HEALTHY HUMAN VOLUNTEERS AND INFORMED CONSENT
Presentation by Andre Menache, BSc(Hons.), BVS, MRCVS,
at Ethics Education in Medical Schools conference in Israel February 13-16, 2000. Dr Menache is President of DLRM
The use of healthy human volunteers is recognised as posing unique ethical, legal and medical dilemmas. The ethical dilemmas may be summed up by the statement that "without some form of payment, most volunteers will not volunteer". (1) Therefore, DLRM call upon medical authorities to replace the term volunteer with a more appropriate term, since the term volunteer, by definition implies "of one's own free will; not prompted by promise or threat." (2)
Another important consideration is the fact that there is still no clear distinction between legal consent and valid consent.(3) The former refers simply to applying one's signature to a document of informed consent. The latter is much harder to define, but is equally, if not more important than the former. This is due largely to the fact that the animal experiments performed prior to the clinical trial are not predictive with any degree of confidence for human beings. (4)
The following facts and quotations lend support to this thesis:
"Animal studies are done for legal reasons and not for scientific reasons. The predictive value of such studies for man is meaningless--which means our research may be meaningless. (5)
"...the best guess for the correlation of adverse reactions in man and animal toxicity data is somewhere between 5% and 25%." (6)
"Most adverse reactions which occur in man cannot be demonstrated, anticipated or avoided by the routine subacute and chronic (animal) toxicity experiment." (7)
According to the US General Accounting Office, of the 102 medications put onto the market between 1976 and 1985, fully 51% of these had to be either withdrawn completely from the market, or else relabeled because of "serious side effects" not noticed previously.
"Most of the animal tests we accept have never been validated. They evolved over the past 20 years and the FDA is comfortable with them. (8)
In June 1993, during phase II trials, 5 out of 15 patients died while two others required emergency liver transplantation for liver and kidney failure: this effect had not been observed in animal species. (9)
Animals and people can react very differently to the same medical drug because of species differences. In fact, animal tests fail to predict the vast majority of human adverse drug reactions--which could explain in part why ADRs account for as much as 5% of all UK hospital admissions and occur in 10-20% of hospital inpatients. (10) Participants in clinical trials (especially phase I healthy human volunteers) are therefore exposed to far greater risks than they can imagine based on the above. Considering the fact that over half a million people take part in clinical trials in the UK every year, this is a huge problem. (11)
Participants in clinical trials (particularly early phase) must therefore always receive written assurances that they, or their next-of-kin, will receive significant guarantees (i.e.no fault) financial compensation (at least on a par with a good life insurance policy), in the event that the participant is damaged or dies. (12) In addition, ethical committees whose task it is to approve or oversee clinical trials should comprise at least 50% non-scientists, as in the Danish system of medical ethics. (13)
(1) Byrony Close: Volunteers in Research and Testing Taylor and Francis Ltd. 1997
(2) The Concise Oxford Dictionary 5th ed. 1964
(3) ibid
(4) The Cruel Deception Dr Robert Sharpe Thorsons publishing group 1988
(5) Dr James D Gallagher, Director of Medical Research of Lederle Laboratories JAMA 14.3.64
(6) Dr Ralph Heywood, past scientific director of Huntington Research Centre: Animal Toxicity Studies: TheirRelevance to Man, Quay 1989
(7) Prof. Gerhard Zbinden, former consultant to WHO. Applied Therapeutics No 8, 1966
(8) Anita O'Connor, Office of Science, FDA 1998 (personal communication)
(9) McKenzie, et al: "Hepatic failure and lactic-acidosis due to fialuridine, etc. NEJM 1996
(10) Pirmohamed et al: BMJ v 316, 25.4.1998
(11) ibid
(12) DLRM 5th International Congress, 4 March 1999
(13) Danish Central Scientific Ethical Committee, Collection of Annexes, Copenhagen 1994
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