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There are reported cases of serious, sometimes life-threatening cases of diabetic ketoacidosis in patients with type 2 diabetes treated with SGLT2-inhibitors. This is reported by the manufacturers after consultation with the European Medicines Agency (EMA) and the Bulgarian Drug Agency (BDA).

In a number of these reports the clinical presentation of the condition is atypical, as only moderately elevated blood glucose levels are observed. The statement says that such atypical clinical presentation of diabetic ketoacidosis in patients with diabetes could delay diagnosis and treatment.

The patients treated with inhibitors of SGLT2, with symptoms of acidosis should be tested for ketones to prevent the delay in diagnosis and treatment.

Cases of diabetic ketoacidosis have also been reported in patients with type 1 diabetes mellitus, who were given inhibitors of SGLT2. The pharmaceutical companies remind the prescribing physicians that type 1 diabetes is not permitted therapeutic indication for this class of drugs.

In Bulgaria dapagliflozin is registered from this class of inhibitors under the trade name Forxiga 100 mg x 30.

During the past 2014 the NHIF allocated 72 million for rare medicines

The innovations are crucial for achieving better treatment, but they are very expensive. Good examples of this are the so called “orphan drugs”, which treat rare diseases. Treatment of a patient for a year could exceed millions. Because of that the access is problematic for every country. The analysis of the Center for Health Technology Assessment and Analysis and the Institute for Rare Diseases shows – where are we in comparison with EU countries.

The ensuring of access for patients to “orphans drugs” across the EU is different. Although the drugs have Marketing Authorization through the Centralized procedure (simultaneously for each country), the payment from public funds is at a different time. According to the data in the analysis of the Centre for Health Technology Assessment and Analysis and the Institute for Rare Diseases the average delay in the countries is 29.1 to 43 months from the receipt of the Marketing Authorization to funding. The analysis examines all 36 diseases that are covered by the NHIF. Among them are congenital coagulopathies (disturbances in blood clotting), beta thalassemia, idiopathic thrombocytopenic purpura, non familial hipogama-globulinaemia, selective deficit of subclasses of immunoglobulin G, severe combined immunodeficiency with low or normal content of B cells, common variable immunodeficiency, etc.

The delay in Bulgaria for the reimbursement of “orphan drugs” is within a few years. The delay in access to medication for mucopolysaccharidosis II for example was 5 years, as was the reimbursement for another medicine for phenylketonuria. The delay in access to “orphan drug” for hereditary amyloid polyneuropathy was 2 years, while to “orphan drug” for primary pulmonary hypertension – 3 years. “This delay represents a significant obstacle to timely and adequate treatment of patients with rare diseases,” says the analysis.

In the middle of last year registered in the EU “orphan drugs” were 72. Of them in Bulgaria the fund and the hospitals pay only 22. The remaining 50 are not funded with public money and in practice remain inaccessible to patients. For comparison, in other member states on average about 80% of the approved on European level “orphan drugs” are included in the health insurance system. Although many drugs remained inaccessible to the sick people in our country, our country has made great progress in recent years in providing access to rare drugs to patients, says the analysis. The costs of the NHIF for such medicines were increase from BGN 28 million in 2011 to over BGN 72 million in the last. The average cost of treatment per patient per month was about BGN 2 thousand

Although some European countries cover more drugs for patients with rare diseases, they also face many challenges. The establishment of the clinical efficacy of these drugs is number one priority, because the evidence is often insufficient from the standpoint of the health authorities. This is due to the limited number of patients who use them, and the required data can not be accumulated quickly. Furthermore, it is difficult to find for comparison a competitive conventional therapy already covered by public funds and available to patients. These problems, combined with the extremely high cost of most of the treatments for rare diseases, raise the question of finding a partnership between the government and the industry in the financing of the drugs. The mechanisms for the management and sharing of financial risks are many. In Belgium, for example, public expenditure on drugs has a limit. 2/3 of the over-expenditure should be covered by the pharmaceutical industry and the rest by the National Health Insurance Institute. In Australia, as early as 2004, the state agreed to reimburse the medicine provided that a registry of patients with primary pulmonary hypertension will be created and the future price will be consistent with the results. In practice the data on the clinical efficacy of treatment locally is required by the authorities in most countries. This is the main reason for the peculiar boom of the registers for rare diseases in Europe. According to the European portal Orphanet the number of registries for rare diseases in the Member States is 641 as of 2014. In this respect Bulgaria was a kind of best performer in Eastern Europe, says the analysis. However, this is clearly not enough. According to the specialists a better control is needed over funding, reallocation of resources according to the effects of treatment and provision of monitoring network for patients with rare diseases.

There are 8000 rare diseases

A disease is considered rare when it affects less than 5 persons in 10 000 in the EU. According to scientists there are between 5000 and 8000 such diagnoses. They will affect between 29 and 32 million people in the EU, of which 400 000 in Bulgaria.

They are mainly against cancer

More than 72 “orphan drugs” are discovered so far. Only for the last two and a half years 27 new drugs have been approved for marketing, 9 of which in the first half of 2014. Most of the designated drugs are intended for cancer. Lysosomal storage disorder and primary pulmonary hypertension are emerging as the next “most preferred” areas of the industry for development of new drugs.

A new front in the National Assembly against the reduced requirements for managers was formed.

The Health Minister Petar Moskov has proposed a liberalization of the requirements for managers in the Medical Institutions Act and virtually anyone who has a master degree in economics may become head of a hospital. This formed a new front of Members of parliament from different groups against the proposal of the Minister.

According to the current law a manager or executive director of a hospital can only be a person who has a master’s in general or dental medicine and acquired qualification in health management.

The other option is a master degree in economics and management, and board certification in medical informatics and health management or health economics.

Now, however, Moskov has proposed in the draft law to eliminate the requirement for qualification in health management, and for the economists to have knowledge in the field of health. In the health committee he explained that if a young man, a graduate of Cambridge, decided that he wanted to pursue a career as Head of St. Anna Hospital, the Members of the Parliament should not impede him.

The Members of Parliament: We will not draft a law for one person.

“I disagree with this proposal; I believe the current requirements should remain because they provide a guaranteed level of competence in management. We will not make laws for an individual from Cambridge. I think we need to draft a law for those who live in Bulgaria. Moreover, after the New Year there will be enough freelance hospital managers who will seek employment,” said the Member of Parliament from the Reformist Bloc Assoc. Prof. Dimitar Shishkov.

Prof. Georgy Kyuchukov from the Alternative for Bulgarian Revival is also adamant that the criteria should not be lowered. “Receiving his education at Cambridge, he will be better informed about the needs of the British health system, but not of ours. Moreover, the opening of a faculty in health management in each medical university losses its meaning,” said Prof. Kyuchukov.

The Member of Parliament from the PP Citizens for European Development of Bulgaria Dr. Krassimir Petrov is also adamant that his party will not allow the lowering of the standards for hospital executives, provided that the reform aims at better management. They will even propose the requirement of master’s degree in health management, not just qualifications. Of the same opinion is Djevdet Chakarov, his colleague from the Movement for Rights and Freedoms. “It is evident that there is a huge need for effective management. The nature of the medical activities and services should be known. The amendments may have a different interpretation – that the door to change the hospital bosses is opened,” said Chakarov.

The results of a retrospective study published in the Journal of the American College of Cardiology show that the patients with critical limb ischemia who took statins had a significantly lower incidence of major adverse cardiac events (MACE) and amputations.

The register of patients with peripheral arterial disease (PAD) from 2006 to 2012 was analized and 380 cases were selected with at least one episode of critical limb ischemia confirmed by angiography with or without endovascular therapy. The average age in the study group was 69 years and the mean follow-up period – 409 days.

The patients were divided into two groups according to whether they are receiving (65%) or not (35%) statins prior to the episode of critical ischemia. The most commonly used statins in the study were simvastatin and atorvastatin.

In the group on statin the frequency of concomitant diseases (diabetes, hypertension, coronary heart disease, myocardial infarction, carotid stenosis, or stroke) was significantly higher.

Despite the higher comorbidity, after one year of follow up of patients receiving statin, the combined endpoint of myocardial infarction, stroke, and mortality was significantly lower (18%) compared with those who were not taking a statin (23%) before and after the incident of critical limb ischemia.

Interesting here is that the mortality is the main factor that determines the difference in frequency of MACE – 15% mortality in the presence and 21% in the absence of statin therapy

The combined risk of death or amputation of a limb is reduced by half when taking a statin.

The survey results support the recommendations in recent clinical guidelines that the administration of statins is indicated for all patients with PAD, even when the disease is in the final stage.

Despite all the strong evidence of the benefit of statins, only 65% ​​of patients in this retrospective study were taking statins. This indicates that the application of the guidelines for behavior in clinical practice has not yet reached the required level.

Tchaikapharma High Quality Medicines Inc. offers on the Bulgarian market the following statins:

Simvacor (Simvastatin) – CF 710 – 10 mg 

Simvacor (Simvastatin) – CF 711 – 20 mg

Simvacor (Simvastatin) – CF 712 – 40 mg

Atorva (Atorvastatin) – CF 996 – 10 mg 

Atorva (Atorvastatin) – CF 997 – 20 mg

Scientists from the Edinburgh University announced that they had found the mechanism that allows breast cancer to spread to the lungs, wrote The Guardian.

The team of scientists found that blocking it in mice with the disease reduced the number of secondary tumors in the lungs. The researchers hope that their achievement would lead to new therapies to stop the breast cancer development. The reason for the majority of deaths in this form of cancer is the penetration of malignant cells in other body parts, the lungs being the first organs affected.

The team from the Centre for Reproductive Health at the University has researched the role of an immune cell called a macrophage in relation to the spread of cancerous cells from the primary tumor. Previous studies have shown that cancer cells use macrophages to penetrate into the lungs. The new study found that macrophages communicate with the cancer cells through chemokine signaling molecules. When these signals in mice are blocked, the number of secondary tumors decreases by up to two thirds. Moreover, the suspension of the signal stopped the entry of malignant cells in the lungs through the bloodstream and prevented the already entrenched cells to form new tumors.
Cells in the human body use chemokines signals to communicate with each other, which gives hope that as a result of the discovery new treatments for other body parts can be created.