The placebo effect, much advertised by psychologists, boils down to the ability to cure oneself by just believing in the effectiveness of any substance whatever. Practitioners’ views are somewhat different. For those making money on the wrong side of the law, the problem has long been solved. Active ingredient is absent in almost 70% of false pills and solutions. Experts believe that this could be even considered a positive aspect, because it means that such sham medicines will not be even worse than the diseases they are meant to treat. On the other hand, just imagine what such a placebo can do if administered for, say, acute peritonitis.
Statistically, an average of 8-15% of $225 billion of the world pharmaceutical market turnover consists of fake medications. This ratio depends primarily on a given country’s economic status (reaching 34% in the developing countries) and is explained by its high profitability and the connivance of law enforcement. Experts insist that those making the modern equivalent of snake oil actually earn more than drug traffickers, while bringing them to account is considerably more difficult. Ukraine is one of those countries where the law is soft on quacks. With 10-20% fake products on the local pharmaceutical market, the management and personnel of an underground factory, if and when exposed, could each receive a couple of years. The state medical quality inspectors, when detecting fake medicines, must first prove damage to consumers and only then can criminal proceedings be initiated. Naturally, the degree of damage caused by a placebo is very difficult to determine, so such medical counterfeiters can get off with a fine.
Serhiy Sur, deputy chief medical quality inspector of Ukraine, says that, although there is a sufficient compulsory quality control clause in the law of Ukraine On Medicinal Products, it should be updated or amended.
Fully aware of the situation, the Ministry of Health is in no hurry to approve the state inspection authority’s proposals. The inspectorate’s effectiveness, as the principal oversight authority on the pharmaceutical market, is declining steadily because it is unable to control certain nuances. For example, under law the state inspectorate can check the quality of medicines, their storage conditions, issue compulsory recommendations, levy fines, draw up statements, and forward incriminating evidence to law enforcement authorities. Yet is not authorized to check pharmacists selling medicines without prescriptions or physicians prescribing such medicines, just as it is not in a position to do anything about advertisers acting contrary to their basic law, which reads that advertising medicines that can be obtained only under prescription is not allowed on billboards, in advertisements, or commercials. Also prohibited is any information to convince one that a certain medicine can be administered without first consulting a physician.
The situation is even worse when the active substance is not just deleted but replaced by another, cheaper one that can have an altogether different effect on the patient — as in the case with streptocide being sold instead of azithromycin or penicillin instead of cephaeline. Fortunately, no accidents have been registered because of antibiotic misuse and the sham agents were timely withdrawn from circulation. The state inspectorate detected forty brands of counterfeit medications last year, most of them originating in Ukraine.
The Kyiv’s chief directorate for the protection of consumer rights is astir with an outrageous case when a woman bought a Monroe set from a telemarketing store. She had learned from ads and commercials that it was meant to improve the shape of breasts. Before paying 2,000 hryvnias, she asked whether the product contained certain phytoconcentrates to which she was allergic. The sales assistant assured her that there were none. Then she had an allergic attack. She had the product examined by a public health and epidemiological authority, whose findings turned out even more intriguing. The herbs contained in the product, causing that woman’s allergy, also had effects contrary to what was stated in the advertising material: they were painkilling and anti-inflammatory.
Similar things happen with medications. Rayisa Bohatyriova, member of the parliament’s committee for health, maternity, and child care, insists that Romed and Aurora mercury-in-glass clinical thermometers have been supplied to Ukraine, allegedly from Holland and Germany, respectively, over the past couple of years, while no such thermometers are officially produced in those countries: they are actually made in China. In addition, tests show that these “Dutch” and “German” thermometers are wrong by several decimals to several degrees. In other words, by measuring one’s temperature and discovering it is, say, 37.6 o C, one will take antipyretic agents, actually having 36.6 o C [normal body temperature on the Centigrade scale].
True, there have been no complaints from people using these thermometers, which is only natural: how can one determine one’s temperature otherwise and who would ever think of testing a “quality” of thermometer, supposedly made in Germany or Holland after buying it?
Germany no longer produces mercury-in-glass thermometers, and Europe has long been using the digital type, which is quite expensive ($1.70 apiece), meaning that such thermometers are practically nonexistent on the Ukrainian market. Instead, there are many fake goodies: some 2.5 million pieces supplied to Ukraine in 2000-01 alone. These are sold at drugstores on the strength of state registration certificates issued by the Ministry of Health’s State Department. Ms. Bohatyriova, however, questions their authenticity. Such thermometers are on sale (cleared at customs without any raised eyebrows, incidentally) as medical products — in other words, VAT-exempt, meaning that the state budget has lost at least UAH 3.2 million. People at the ministry agree that Chinese thermometers are not entered in the state register of medical equipment and medical products. Anatoly Kartysh, assistant state secretary of the ministry, admits that selling Chinese thermometers in Ukraine is against the law, but they are on sale nonetheless.
Drugstores and other health institutions allow more transgressions. Adding to the statistics of defective medicines are those past the use-by date or kept under improper storage conditions. Medical distributors insist that the Ukrainian legislation is such that disposing of defective medicines is far more complicated than selling them. The existing legal framework contains references to numerous authorities that must allow the destruction of defective medications.
When confronted with all this, state structures respond the usual way: if you want to change something, go right ahead. In all countries, associations of manufacturers and distributors most actively participate in the pharmaceutical legislative process, because they suffer from market falsifications and defective products almost as much as the consumer. In Ukraine, no drafts have been submitted to the pertinent authorities by the association of manufacturers or that of distributors. Their objections remain on the level of emotional speeches at board meetings and conventions.
