Criticisms Of Modern Drugs

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Extremist critics have attracted public attention for their view that modern drug therapy, indeed modern medicine in general, does more harm than good; others, whilst admitting some benefits from drugs, insist that this is medically marginal. These opinions rest on the undisputed fact that favourable trends in many diseases preceded the introduction of modern drugs and were due to economic and environmental changes, sanitation, nutrition and housing. They also rest on the claim that drugs have not changed expectation of life or mortality (as measured by national mortality statistics) and that drugs can cause illness (adverse reactions).

If something is to be measured then the correct criteria must be chosen. Overall mortality figures are an extremely crude and often an irrelevant measure of the effects of drugs whose major benefits are so often on quality of life rather than on its quantity.

Two examples of inappropriate measurements will suffice:

1. In the case of many infections it is not disputed that environmental changes have had a greater beneficial effect on health than the subsequently introduced antimicrobials. But this does not mean that environmental improvements alone are sufficient in the fight against infections. When comparisons of illnesses in the pre- and post-antimicrobial eras are made, like is not compared with like. Environmental changes achieved their results when mortality from

12 Bates DW et al. 1995 incidence of adverse drug events and potential adverse drug events. lournal of the American Medical Association 274: 29-34.

infections was high and antimicrobials were not available; antimicrobials were introduced later against a background of low mortality as well as of environmental change; decades separate the two parts of the comparison, and observers, diagnostic criteria and data recording changed during this long period. It is evident that determining the value of antimicrobials is not simply a matter of looking at mortality rates. 2. About 1% of the UK population has diabetes mellitus and about 1% of death certificates mention diabetes. This is no surprise because all must die and insulin is no cure13 for this lifelong disease. A standard medical textbook of 1907 stated that juvenile-onset 'diabetes is in all cases a grave disease, and the subjects are regarded by all assurance companies as uninsurable lives: life seems to hang by a thread, a thread often cut by a very trifling accident'. Most, if not all, life insurance companies now accept young people with diabetes with no or only modest financial penalty, the premium of a person 5-10 years older. Before insulin replacement therapy was available few survived beyond 3 years14 after diagnosis; they died for lack of insulin. It is unjustified to assert that a treatment is worthless just because its mention on death certificates (whether as a prime or as a contributory cause) has not declined. The relevant criteria for juvenile-onset diabetes are change in the age at which the subjects die and the quality of life between diagnosis and death, and both of these have changed enormously.

DRUG-INDUCED INJURY15 (see also Ch. 8)

Responsibility for drug-induced injury raises important issues affecting medical practice and development of needed new drugs, as well as of law and of social justice.

13 A cure eliminates a disease and may be withdrawn when this is achieved.

14 Even if given the best treatment. 'Opium alone stands the test of experience as a remedy capable of limiting the progress of the disease', wrote the great Sir William Osier, successively Professor of Medicine in Pennsylvania, McGill, Johns Hopkins and Oxford Universities, in 1918, only three years before the discovery of insulin.

They used to have a more equitable contract in Egypt: for the first three days the doctor took on the patient at the patient's risk and peril: when the three days were up, the risks and perils were the doctor's.

But doctors are lucky: the sun shines on their successes and the earth hides their failures.16

Negligence and strict and no-fault liability

All civilised legal systems provide for compensation to be paid to a person injured as a result of using a product of any kind that is defective due to negligence (fault: failure to exercise reasonable care).17 But there is a growing opinion that special compensation for serious personal injury, beyond the modest sums that general social security systems provide, should be automatic and not dependent on fault and proof of fault of the producer, i.e. there should be 'liability irrespective of fault', 'no-fault liability' or 'strict liability'.18 After all, victims need assistance (compensation) regardless of the cause of injury and whether or not the producer and, in the case of drugs, the prescriber deserves censure. The question why a person who has suffered injury due to the biological accident of disease should have to depend on social security payments whilst and identical injury due to a drug (in the absence of fault) should attract special added compensation receives no persuasive answer except that this is what society seems to want.

Many countries are now revising their laws on liability for personal injury due to manufactured

15 This discussion is about drugs that have been properly manufactured and meet proper standards, e.g. of purity, stability, as laid down by regulatory bodies or pharmacopoeias. A manufacturing defect would be dealt with in a way no different from manufacturing errors in other products.

16 Michael de Montaigne 1533-92. French essayist.

17 A plaintiff (person who believes he/she has been injured) seeking to obtain compensation from a defendant (via the law of negligence) must prove three things; 1, that the defendant owed a duty of care to the plaintiff; 2, that the defendant failed to exercise reasonable care; and 3, that the plaintiff has a suffered actual injury as a result.

18 The following distinction is made in some discussions of product liability. Strict liability: compensation is provided by the producer/manufacturer. No-fault liability or scheme: compensation is provided by a central fund.

products and are legislating Consumer Protection Acts (Statutes) which include medicines, for 'drugs represent the class of product in respect of which there has been the greatest pressure for surer compensation in cases of injury'.19

Issues that are central to the debate include:

• Capacity to cause harm is inherent in drugs in a way that sets them apart from other manufactured products; and harm often occurs in the absence of fault.

• Safety, i.e. the degree of safety that a person is entitled to expect, and adverse effects that should be accepted without complaint, must often be a matter of opinion and will vary with the disease being treated, e.g. cancer or insomnia.

• Causation, i.e. proof that the drug in fact caused the injury, is often impossible, particularly where it increases the incidence of a disease that occurs naturally.

• Contributory negligence. Should compensation be reduced in smokers and drinkers where there is evidence that these pleasure-drugs increase liability to adverse reactions to therapeutic drugs?

• The concept of defect, i.e. whether the drug or the prescriber or indeed the patient can be said to be 'defective' so as to attract liability, is a highly complex matter and indeed is a curious concept as applied to medicine.

Nowhere has a scheme that meets all the major difficulties yet been implemented. This is not because there has been too little thought, it is because the subject is so difficult.

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