Problem Medicine – PART 1
Every drug carries a risk. It is impossible to create any chemical substance which would not create any risk neither for women, nor for men; as though it was accepted: through a mouth, a nose, an eye retina, subcutaneously, rectally or vaginally.
It is tempting to focus only on those drugs, the risk of which is obvious. But there would be a misconception that the problem lies only in these few substances, and that if we deal with them, we will have only those drugs that are of high quality, meet real medical needs, and are effective and affordable. Unfortunately, as many examples in this book show, this is not the case. The problem is not created by a few dangerous drugs that promote one or two dishonest pharmaceutical companies to the market. This is an inevitable result of the structure and activities of the pharmaceutical market.
The problem with the drug is not because of its inherent pharmacological risk, but as a result of how it is prescribed and used. It is impossible to talk about the “safety” of medicines as a laboratory problem. In the wrong hands and at the wrong time, even a drug that has passed the most thorough quality control, turns from the Savior of life into a threat to her. In some cases, the consequences may not affect a single patient or group of patients, but the whole world.
The best example of this is the misuse of antibiotics, as a result of which many bacteria are now developing resistance to cheaper and safer medicines. One researcher notes that “antimicrobial resistance has become a global problem that has a major impact on health care in developed and developing countries“. This is a consequence of the widespread and misuse of antimicrobial medicines for humans and animals. One example of such misuse is the inclusion of antibiotics in combination drugs for the treatment of diarrhea. This is an unreasonable, dangerous, and useless practice, because most diarrhoea is caused by viruses that do not respond to antibiotics. Nevertheless, the antibiotic contained almost two out of every three antidiarrheal drugs available on the market of 12 Latin American countries in 1990.
Another problem is that modern drug testing procedures do not allow the collection of some information about their safety before obtaining a permit to use and start marketing. This is because the majority of patients participating in the drug’s pre-marketing clinical trials have a relatively uncomplicated picture of the disease and are recruited from limited age groups. Demarketing test was described as “too few, too simple, too narrow, too average age and too short”. Thus, for example, pregnant women, children and the elderly are often excluded from them, although they may be exposed to this drug after marketing.
Women make up about 52% of the world’s population; children under 15 – about 32%, people over 65 – about 6%. Taken together, at least two thirds of the world’s population belong to the category of “special cases” in which greater care is needed in the use of drugs, and for which less is known about the consequences of the use of drugs. These people also make up the groups that are most likely to use the drugs.
Since the limitations of pre-marketing clinical trials do not allow to predict the side effects (PE) of the drug at the time of its appearance on the market, all manufacturers need to develop and conduct post-marketing observations. Their results should be submitted to the regulatory authorities within a specified period of time after administration of this drug.
A Canadian study found that PE drugs are most likely in women and people over 50 years of age. This is most likely due to the large number of drugs consumed by both groups. In General, somewhere between 5% and 20% of hospital admissions are caused by PE drugs. Although it is generally accepted that more serious PE drugs (in which hospitalization is required) are diagnosed fairly accurately, less serious, but no less disturbing PE drugs are registered by conventional spontaneous information services is not completely, and perhaps only in the amount of 2%