Gajski Presentation Bruxelles 18 9 13

7/27/2019 Gajski Presentation Bruxelles 18 9 13

1/3

Workshop on Effectiveness of Medicines and Therapies, Brussels, 18 September 2013 Presentation by Lidija Gajski, page 1

Workshop on "Effectiveness of Medicines and Therapies"

18 September 2013, European Parliament, Brussels

Useful, superfluous, unnecessary and dangerous drugs

Presentation by Lidija Gajski

Dear ladies and gentlemen,

Thank you for inviting me to participate in the workshop. I was asked to talk about drugs,

which will inevitably lead to drug science, drug policy etc.

Let me start with one simple classification of the medication curative drugs eliminate the

disease; they are clearly beneficial. There is also no doubt about the need and efficiency of

numerous groups of symptomatic drugs; I pointed out substitution pharmacotherapy which

literally saves lives insulin in type I diabetes, for example. What is less clear is the need for

and effectiveness of preventive drugs ones that are given to the people with no symptoms of

disease.

Lets start with those that consume the most of the money. Clinical trials of 3-5 years

duration show that in people with cardiovascular disease or high cardiovascular risk,

antihypertensives, hypolipidemics and aspirin reduce the rate of cardiovascular events fromapproximately 4.5% to 2.5 3% per year, i.e. about 80 patients must be treated to prevent

one heart attack or stroke. In healthy population with low cardiovascular risk, reduction of

unwanted events is from about 0.8% to 0.5%, or it takes a few hundred people to treat, in

order to prevent one unwanted event. There is no evidence whatsoever that these drugs

prolong life in the latter population, i.e. when given for primary prevention. As for

antidiabetics, strict pharmacological regulation of blood sugar saves one complication of

diabetes (mostly minor eye operation) in 200 patients treated, per year. The effect of drugs for

osteoporosis on the only really relevant bone fracture the hip fracture, in clinical trials was

below statistical significance. Hormone replacement therapy is a symptomatic therapy; there

are no benefits in prevention of future disease. Obesity drugs have minimal effect on weight

loss; capacity to prevent disease unknown; well, it is known for some agents which have

been found harmful. Antidepressants prevent neither suicide, nor new episodes of depression;

even as a symptomatic therapy, except for severe depression, they are equivalent to placebo.

Chemotherapy works for some relatively rare types of tumours, notably hematologic; the most

common cancers are resistant to cytotoxic agents. Antiviral drugs very limited effects.

Whether vaccines actually prevent infectious diseases is not known, because proper studies

have never been performed.

Data regarding efficacy which I have presented derive from the scientific research (it wasimpossible to cite all the literature), mostly clinical trials; efficiency in real life is even smaller


2/3


for many reasons limitations of the clinical trial itself in the first place. What deserves

special attention in this context is funding numerous evidence and scandals show that

industry manipulates the results of drug trials to make their products look better than they

really are. Studies which have analysed the relationship between outcomes of the studies and

their sponsorship found that those financed by pharmaceutical companies are four to fivetimes more likely to produce results in favour of the sponsor, compared to studies paid from

other sources. And the drug industry finances about 70% of the clinical trials published in

major journals.

By taking over the scientific research pharmaceutical industry not only overestimates the

drug benefits, but broadens the drug indications as well. Special populations and special

outcomes are created in which the effect of the substance is demonstrated. Antidepressants,

formerly given for severe forms of depression only, now have twelve indications including

milder anxiety disorders. Statins have evolved from cholesterol lowering drugs in patients

with coronary heart disease, into universally beneficial anti-atherosclerotic medication.

Industry sponsored epidemiological studies exaggerate disease prognosis and prevalence flu

has become a life threatening disease; one twelfth of mankind is infected with hepatitis virus.

Next expanding disease definition clinical trials simply found that drugs are effective in

milder forms of disease like asthma and depression and in physiological or borderline

conditions, or temporary disorders; these conditions are then pronounced illnesses. Thanks to

the observational studies which have shown benefit of blood pressure lowering, the number of

hypertensive people has increased from 20% to 44%. Finally, inventing new diseases 30

years ago anyone hardly knew of cholesterol, which was right since it is more or less

unimportant biological parameter; thanks to manipulated scientific studies and a concept ofcardiovascular risk, it has become the main topic in the doctor's office. Next concept, applied

in the case of osteoporosis youth equals health, old age equals disease. Menopause normal

period of life turned into disease; Helicobacter pylori majority of people have it; the

abundance of newly created psychiatric entities; example social anxiety disorder, formerly

known as shyness.

And here we are, talking about healthy people, people whose manifestations of normal life

have been medicalized. This is where the drugs don't belong. Methodologically rigorous and

correctly interpreted trials show no effect of drugs in either of these conditions. Same goes for

prevention. We are witnessing a medical paradigm shift from traditionally curative topreventive. There is nothing wrong with the prevention of disease, of course, but we are

talking about pharmacological prevention here, and it is in the primary prevention setting far

from cost-effective. Pharmacological prevention is the concept of drug industry, which has in

the last few decades consumed the really ill and discovered an endless market and

enormous profit prospects in the healthy population. It is a distortion and abuse of the very

term of prevention and preventive approach. And it causes harm medical, economic, social

and cultural.


3/3


Ivan Illich, a brilliant critic of modern society, of Croatian origin I must say, anticipated

almost 40 years ago what has now become obvious to many insiders and outsiders of

medicine.

Talking about the harm that medication causes, let me focus on the direct, medical harm

only. Studies show that every fourth prescription drug user experiences an adverse event.

Among the side effects recorded in hospitals, around 1% was fatal, 12% were life-threatening

and 30% serious. A meta-analysis showed that the incidence of serious side effects occurring

while in hospital plus those causing admission to hospital is 6.7%; 0.32% were lethal. Authors

estimated that it equals 106 000 of deaths in USA every year, making drugs between the

fourth and sixth leading cause of death. A similar study demonstrated 6.5% adverse drug

reactions in UK hospitals, of which 0.15% were fatal. It is very important to stress that these

numbers differ very much from the official statistics, which substantially underestimates

pharmacotherapy-induced harm.

How come the substances intended for cure are so harmful?

First, their use is increasing, with the growing possibility of unpredictable interactions and

errors on the part of both the doctor and the patient. Second, insufficient testing adverse

drug events are not sufficiently explored, they get underreported in the studies and interpreted

in the way that minimizes their significance no wonder, knowing who pays for the studies.

Many think that the drug approval process is too lax. Regulatory agencies licence drugs on the

basis of the relatively small number of studies, often of short duration, sometimes including

only surrogate outcome measures, and, most importantly, with the possibility of coming

exclusively from the industry (I wouldn't know that firsthand, I'm citing other people). This is,again, the result of the influence pharmaceutical companies have in the regulatory bodies, by

financing them through paying for licencing procedure and by having their lobbyists among

the staff. Insufficiently tested pharmaceuticals come into use and later are recalled because of

toxicity. Thanks to postmarketing surveillance, which is, however, also inadequate. Only 5%

to 20% of side effects are reported. Why? There are no sanctions for non-reporting,

physicians are insufficiently educated and sensitized, and fear of liability; companies are not

interested for obvious reasons and state agencies are understaffed and underpaid.

How to achieve a rational drug policy? By dealing with the conflict of interest. The prime

duty of the industry is earning money and it is perfectly legitimate. The ones who have failed

are the civil servants paid by the public money who have exchanged their primary for the

secondary interest. Solution is not in the actual non-productive conflict of interest-regulation

approach, but in its elimination, meaning exclusion or strong reduction of the corporate

influence, i.e. private money from the scientific research, professional education, public

opinion creation and the drug regulation.

Documents

Gajski Presentation Bruxelles 18 9 13