Insulin resistance and beta-cell dysfunction are the two key pathophysiological disorders of diabetes mellitus type 2 (DM T2). The liver, muscle and the adipose tissue are resistant to insulin action. The basal hepatic glucose output is increased, despite the high plasma insulin levels, indicating the presence of hepatic insulin resistance. Increased glucose production by the […]
Diabetes mellitus is a major risk factor for the development of cardiovascular and cerebrovascular morbidity and mortality. Despite the greater and more widespread “diabetes mellitus” problem awareness and the application of new therapeutic agents in Bulgaria, as in other European countries and the US, the metabolic control of diabetes in more than half the time […]
Arterial hypertension (AH) is the most common cardiovascular disease. It is the most common cause of morbidity and mortality worldwide every year. Hypertension is the main cause of cardiovascular disease (CVD) and mortality worldwide. Although scientists and doctors have made significant efforts to control blood pressure and have great achievements in this direction, there still […]
The good news is that the General practitioners will be able to provide referrals easier The hospitals that provide emergency admission of patients this year will receive up to 95 percent of the amounts they had in 2014. The health care institutions that do not offer emergency admissions will receive up to 90 percent of […]
BGN 750 million cost home care per year, they save with limits for mediicnes as with medical referals The expenditures on medicines provoded free or with a discount by the National Health Insurance Fund increased three times in less than three years. The amount for medicines for home treatment rose from BGN 250 million to […]
The hexa- and pentavalent baby vaccines, which had been blocked for several months because of a shortage of quantities and the failure of public tenders for suppliers, have been provided. In October, the caretaker Minister of Health said that the two types of vaccines will be available by the end of November, but late last […]
Another year in which health is assigned a lot less money than the sums which are expected to be consumed, and then the budget of the main payer – the Health Insurance Fund – has to be updated or payments have to be postponed is coming to an end. This is another year in which […]
The clinic “La Prairie” in the Swiss city of Montreux is famous for its patented therapy with an extract from the liver of an embryo of the black sheep. And this is not new. The beginning was in 1931 and its founder – Dr. Paul Niehans. He found that injections of live cells from unborn […]
Besides the diagnosis and treatment of diseases a major step towards a healthier life is prevention. Especially in what we consume. A true technological breakthrough was made by the small company Consumer Physics from Israel. Their creation SCiO is as big as the normal flash memory, but it has great features. It is the first […]
In the science fiction series “Star Trek” there is a device that fits into the hand and after a quick scan of the human body it manages to understand whether there is a health problem. It does not cure, but diagnoses without contact with the patient. Its name is tricoder. In 2012, the corporation Qualcomm […]
“Google” is developing contact lenses with a sensor that will measure blood sugar. This is good news for all diabetics, who have to measure it daily and in a painful way. The information collected with the contacts will be able to be transmitted wirelessly through a small antenna. The data will be received by a […]
It is striking that in our technological modernity we are looking forward to travelling to Mars, and yet we have failed as a civilization to cure diseases that affect the lives of many people on the planet. A good piece of news has come from Google. The software giant grew so much last year that […]
Nanomedicine has set another difficult task for itself – to relieve diabetics from the constant use of needles. Instead, they will take the necessary insulin in pill form. At present, patients can receive the substance only as an injection. The reason – it is difficult to absorb in the intestines when taken orally. A team […]
The American scientist James Baker of the University of Michigan has made a huge step in this direction. Thanks to his longstanding research he has developed nanoparticles that are “taught” to target drugs directly to cancer cells. They pass through the different barriers, such as the walls of blood vessels. Once they find diseased cells, […]
From 2015 doctors will monitor the condition of pregnant Bulgarian women via Smartphones It will no longer be necessary to go on foot to the doctor’s office for advice. Instead, every pregnant woman will have the privilege to monitor the heartbeat of the child through a special widget and it will transmit the received data […]
The VAT on medicines is one of the burning issues that politicians have to solve. According to patient organizations and the Bulgarian Pharmaceutical Union it is unacceptable to pay 20 per cent VAT on drugs in Bulgaria, while in Greece the levy is 6%, and in Romania – 9%. In the other countries of the […]
The reform plan of the Health Minister enters the Cabinet in two weeks’ time Restructuring the healthcare system financing – this is one of the measures that the Health Minister Petar Moskov is preparing as part of a legislative package, which will be submitted to the Council of Ministers by the end of the month. […]
As results from the meta-analysis published in the journal American Journal of Cardiology have shown, compared with other beta-blockers (BB), carvedilol displays some additional benefits (improved prognosis) in patients with heart failure (HF) and acute myocardial infarction (AMI). The guides for conduct for acute coronary syndrome, AMI and HF recommend BB as drugs of first […]
With the update of the budget of the MH the payments will be resumed The last money paid to doctors as compensation for pensioners’ user fee for was for the month of July. The sum amounted to 1,592,096 BGN, and the payment was made only in September. This was indicated in a reference from the […]
“Our team’s decision not to increase health contribution is firm. We are absolutely certain.” – This is what the new Deputy Health Minister Dr. Vanya Sharkov said. When he was asked how then more revenue will come into the health system, he said: “More budget revenue can come after a decision of the Council of […]
A responsibility of the Ministry of Health and the Cabinet is that the budget health expenditure for the next year does not exceed what will be accepted as a final healthcare budget for 2014, said the Health Minister Dr. Petar Moskov in discussing the bill for amending the Law on the National Health Insurance Fund. […]
Pathogenesis The basis of the pathogenesis of peptic ulcer is the imbalance between aggressive factors and gastric pepsin, on one hand, and the mucosal barrier, on the other. Among the environmental factors leading to increased gastric secretion, are: smoking, excessive use of alcohol, non-steroidal anti-inflammatory drugs (NSAIDs), emotional stress and other psychosocial factors. The relationship […]
Doctors insist on restructuring Emergency Services The Bulgarian Medical Association and the Bulgarian Society for Emergency Medicine want restructuring of the Emergency Services. The doctors insist on introducing special protocols for emergency calls in hospital and outpatient care. This way those who need medical care will be categorized depending on their condition. The protocols will […]
There is a winner for supplying the hexavalent vaccine. This was stated by Caretaker Health Minister Dr. Miroslav Nenkov from the Council of Ministers, cited by the agencies. The deadline for appealing the choice is ten days. According to Minister Nenkov, “if no one remembers to appeal”, after this deadline passes an agreement with the […]
500 million BGN are being cut from the insurance of the officials The insurance contribution, which everyone pays, has to be increased by 12% starting next year, and the increase has to be 1% on an year by year basis – this proposal will be made by Bulgarian Medical Association (BMA) to the new healthcare […]
The introduction of the system of diagnostically linked groups (DLG) in Bulgaria is postponed for a year. This becomes clear from the changes in Regulation 42 of the Health Ministry, published by the Ministry for public comment. The Regulation introduces an abridged version of the Australian classification of medical procedures – a Bulgarian revision, which […]
The peptic ulcer is a disease of the stomach and / or of the duodenum, which is characterized by the appearance of an ulcerative defect due to the peptic action of hydrochloric acid. The incidence of the peptic ulcer is 6-10% of the population, while the ratio of the duodenal and gastric ulcer is 4:1. […]
Now the ambulances are rarely called without reason. Dr. George Gelev proposes the starting salary of physicians to be BGN 1 500. – Dr. Gelev, what you found in the Centre for Emergency Medical Care (CEMC) – Sofia, is there a change to what you left? – I did not find any significant difference. If […]
The National Council on prices and reimbursement of medicinal products is working on a project that should provide citizens with access to information about medicines by SMS exchange and mobile applications for operating systems Android, iOS and Windows Phone. This was announced from there. The project will also provide Internet access to the contents of […]
The amounts increase by millions according to the figures from the reference of the Social Insurance Institute Record increase in sick pay funds by the NSSI. The amounts increase by millions according to the figures from the reference of the Social Security Institute. It turns out that for the first nine months of the year, […]
The Medical Association probably will not sign the National Frame Agreement (NFA) 2015, if the methodology for valuation and payment is not restored in the frame agreement. This is evident from the information of the professional organization on the progress of the negotiations on the new NFA. “According to my calculations we are talking about […]
The gastroesophageal reflux disease (GERD) is a condition in which the return of stomach contents into the esophagus causes troublesome symptoms or complications. The suffering occurs due to disorders in existing anti-reflux mechanisms that normally prevent the entry of gastric contents into the esophagus. The reflux itself is not an illness. About half of the […]
According to the latest guidelines of GOLD (Global Initiative for Chronic Obstructive Lung Disease), the antibiotic treatment has a good effect on lung function and is recommended for acute exacerbation of chronic obstructive pulmonary disease (COPD) in patients whose progressive dyspnea and cough are accompanied by increased expectoration and purulent sputum. The exacerbations (episodes of […]
The project for emergency cardiac surgery treatment of patients with cardiovascular diseases continues to expand. After the National Cardiology Hospital, Tokuda Hospital, the University Hospital St. Ekaterina the initiative of the BCI was joined by City Clinic Sofia. The program includes specialized medical airlift for patients in urgent need of life-saving cardiac surgery operation. Last […]
The NHIF is expecting the transfer of BGN 9 million from the MH, and the money will be used for the medicines for hospital care. This was conveyed to Zdrave.net by the patients’ representative in the Supervisory Board of the NHIF Petko Kenanov. He informed that at yesterday’s meeting of the Supervisory Board a decision […]
The bacterial infections of the upper and lower respiratory tract acquired in the community are some of the most common reasons for seeking medical care in the developed countries. The acute bacterial rhinosinusitis, exacerbation of chronic bronchitis and pneumonia cause high morbidity. And the infections of the lower respiratory tract, especially after a viral infection, […]
Or how an ethical issue emerging from the poor rule of law in developing countries is used by manufacturers of patented pharmaceuticals in their propaganda war against generic drug manufacturers in the US and Europe.
The hazard for patients and healthcare posed by counterfeit medicines is a problem, which has gained considerable publicity in the last 25 years. A large number of legal or semi-legal pharmaceutical manufacturers in countries with underdeveloped regulatory systems and inadequate capacity for government control take advantage of the increase in the international exchange of goods and internet trade. Mediators from across the world contribute to the distribution of counterfeit copies of popular medicines. We are not talking about parallel trade authorized in Europe but about free seekers of fast and easy profits in the illegal distribution of medicines.
There is no international law definition of “counterfeit medicine” and the working definition of WHO is generally used: “А counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.” (see
The manufacture and distribution of counterfeit medicines can and does affect both brand name pharmaceuticals and generic pharmaceuticals. The genuine author and manufacturer remain obscure and do not have the authority to produce the forged copy. This is why we prefer the definition that counterfeit medicines are trademark medicines not manufactured by the holder of the trademark or without the holder’s permission.
The major global criticism to WHO today is not so much about the inoperative definition but about the high priority focus on the counterfeit medicines campaign instead of on the strengthening of the regulatory procedures and ensuring high quality, safe and efficient pharmaceuticals. Things have gone so far that a big shipment of Indian generic pharmaceuticals for Latin America was withheld in Rotterdam by the Dutch police, inaccurately applying the European Border Measures Regulation, due to suspicions for counterfeit medicines trade instigated by Merck Sharp & Dohme. (See http://digital.findpharma.com/nxtbooks/advanstaruk/pee_digest_20100609/#/4).
The negative consequences are in the aspects of law, healthcare and economy. The first type of consequence is associated with the lack of a functional international law mechanism for control and law enforcement in many countries and with the reliability of the huge amount of information. It almost seems as if WHO officials, in an agreement with Big Pharma (like in the swine flu fraud when billions of dollars were swiped from dozens of countries’ national budgets in what was essentially a highway robbery,) have left rule-making and law administration to the mercy of national court systems. In countries with developed brand name pharmaceuticals, magistrates are inclined to favor their own corporate groups, and magistrates in developing countries are often corruptible in favor of those groups.
The second serious consequence is the high and immediate risk counterfeit pharmaceuticals pose to the life and health of patients who take them. Those are “medicines” without an active ingredient, with an active ingredient in a smaller quantity than is indicated on the packaging, with unstable active ingredient, with decay products exceeding safety standards, with inappropriate pharmaceutical formulation or a formulation which does not ensure adequate release, and many other fraudulent deviations.
The third consequence is a result of the violation of patent rights held by manufacturers of patented pharmaceuticals or of the copyright and trademarks owned by generic manufacturers. In this case counterfeit medicines fully match the original drug’s specifications – that is, they cover all quality criteria and therefore are copies of the generic products, but have not been duly registered. In such cases there may not be a direct hazard to patients’ life and health. However, substantial loss or opportunity costs are incurred by pharmaceutical companies which abide by the law and adhere to international agreements.
Regardless of what specific harmful consequences counterfeit medicines have, the problems they create must be widely publicized and the persons benefitting from their illegal manufacture and trading must be handled with any possible means provided by law, including through incriminating manufacture, by the competent authorities in developing and developed countries.
But how do patented pharmaceutical manufacturers make use of the great discontent with counterfeit medicines in their propaganda campaigns against generic manufacturers?
It is customary to accept innovative, or patented, pharmaceutical manufacturers as inventors of new pharmaceuticals who invest substantial amounts of their profit into scientific research. This myth, created and sustained by their powerful PR-agents in the previous century, is intended to divert public attention from the shamelessly large profits of corporate groups towards the socially pleasing area of research and development.
A large number of the new molecules are in fact discovered in universities or in small, private and independent laboratories sponsored by governmental public or private foundations. Big Pharma buys these molecules, completes the research and development work with a significantly reduced risk, registers the product under their ownership, and markets it on a monopolistic price. Their work is of course crucial for the emergence of a new medicine, but the main financial risks associated with its development are in one way or another undertaken by society, not by the marketer.
It is those financial risks and expenses which form the basis of the exaggerated claims made by “original” drug manufacturers regarding the high prices and prolonged patent protection for their medicines. Modern pharmaceutical companies constitute enormous corporate groups with overblown marketing structures financed by stock markets. No corporate group spends more than 7% of its gross income on research and development, and none spends less than 45% of its gross income on marketing and market penetration. In other words, 45% is being spent to explain to the public the innovative way in which this 7% is spent. Hard-pressed by the requirement to report results for each quarter and by the increased amount of distributed dividends, in reality Big Pharma cannot afford to make risky investments in scientific endeavors – from being inventors and manufacturers they change to being vendors.
The generic manufacturer, on the other hand, creates and registers medicines with quality and safety equivalent to the brand pharmaceuticals. There is no difference between regulatory requirements for the two types of products, although of course the brand one is initially determined as a reference one. Moreover, generic medicines sometimes comply with higher criteria at registration, because it is done at least 20 years after the launch of the patented pharmaceutical, and accumulated scientific data and experience during this period lead to higher requirements for the product. The task of a generic manufacturer is to achieve equal quality and efficacy and bring the price of the medicine to the necessary minimum without a risk to its safety of manufacture and use. The socially valuable role of generic manufacturers is to drive down the cost of treatment of patients and thus save on personal and public resources.
Today Big Pharma is pressed by an increase in marketing expenditure and dwindling profits as a consequence of fewer new molecules reaching the market and the “me too” products they themselves produce. To slow these tendencies, the brand manufacturers organize public campaigns to hinder the penetration of generic pharmaceuticals on the market, like the unwarranted stirring of the counterfeit medicines debate in Europe, where such debate is non-existent. All sorts of fabricated stories and perfunctory tricks are employed in attempts to extend patent and other protections, like data exclusivity of patented products, and to restrict governmental and health organizations’ influence over their prices. They aim to undermine public and medical specialists’ confidence in generic medicines. The most powerful forum covertly attending to this aim is IMPACT
(http://www.who.int/impact/en/index.html). A number of developing countries voiced their explicit protest against the lack of distinction between counterfeit and generic medicines during the last World Health Assembly which took place in Geneva in May 2010 (see the incomplete working document WHO/ACM/1, 4 May 2010, WHO).
Non-public attacks against the influx of generic medicines are quite bluntly featured in spoken communication between corporations and medical specialists – from the vulgar “…those are no good. They’re whipped up in some dirty basement…” to the refined “term” “generic copies”. The negative effect is accomplished by manipulating the unfavorable social attitude towards the idea of a “copy” and using it with regard to generic products. All too often companies’ “concern” with the life and health of the people lead them to compare their product against generics and illegal copies, the latter two being lumped together with only “copies” mentioned in the discussion, while the issues of price, registration and quality are completely left out.
It is very important that we as citizens be aware that a generic product, whether it is referred to as a copy or not, is legally registered and of known quality which, if not higher, is at least equal to the brand name counterpart’s. Medical specialists are not authorized to make public assessments of the “copy’s” quality and efficacy, referring by “copy” to generics. They are only obliged to notify the Bulgarian Drug Agency (BDA) in the stipulated manner if a specific medicine is under suspicion. BDA is obligated by law to make assessments of the quality and efficacy of any medicine.
It is also very important that we as citizens know for whom and to what purpose we spend our public and private funds. Know whether we spend enormous amounts of money to pay for marketing expenses and the multimillion-dollar bonuses of Big Pharma executives, or for the “discovery” of new molecules, which we have already paid for through public funding of scientific research and through the monopolistic prices charged throughout the 20 years’ duration of patent protection. Or whether we make regular insurance contributions for an accessible and quality treatment!