Take It Or Die

Distribution of insulin from humanitarian aid to Belgrade's state pharmacies some two weeks ago is more than sign that there is something seriously wrong in the market for medical drugs.  The insulin which arrived literally disappeared up in smoke, in certain pharmacies in less than a half hour.  Eyewitnesses, diabetics, tell stories of long lines, the breaking of windows in one pharmacy and alleged pointing of a gun.  The main battle was waged around the Nova Nordisk human insulin which is used in the so-called pen therapy.  Beside insulin from Nova Nordisk, the humanitarian relief package also included insulin bottled produced by Hemofarm, which were rarely seen in pharmacies in recent days.

One other circumstance was a cause for further anxiety for local diabetics and not just for them: Serbian government officials recently announced the import of raw materials, finished products and animal insulin of pig origins from China which, according to their assessments will considerably reduce the shortage of medicaments, especially those for chronic patients, and even diabetics.

The Indian medical drugs syndrome, which occurred here a while back (the cause was the import of medical drugs from that country), and which manifested itself in terms of loud public reactions by a public that was used to well known European and world manufacturers of raw materials and medicaments with which the once well-off local pharmaceutical industry cooperated exclusively, pales by comparison with the reactions produced by the Chinese suppliers of medicaments.  All health conscious citizens are peering carefully into packaging of medical drugs, trying to find out traces of Chinese origins in health products.  If they suspect Chinese origins of a product, they invariably return it.  The wealthier consumers buy foreign medication in private pharmacies or order it from regions of the former Yugoslavia.

DEADLY ERRORS: Diabetics are a group of patients who can have serious complications from mistakes in dosage, from improper use of insulin, from its purity or impurity.  Such complications can easily result in death or in permanent consequences to the health of patients.  Diabetics are forced to live with their condition their entire lives, and any problems in the supply of insulin which they cannot do without on a daily basis, naturally causes horrible uncertainty and added fear of complications or even death.  Both because of the seriousness of their condition and because of the decent economic standards we used to live in, those ailing from diabetes managed to get a high level of medical treatment which included well purified insulin and an efficient way of administering it.  According to the still current law on the healthcare of the population, diabetes is included among those illnesses whose treatment is completely financed by the state.

Today diabetics are standing in lines for medication which they cannot do without.  In practice it looks like this: first you must go to a doctor who writes for you all the different kinds of insulin you can take, because the one you have been taking for years is no longer available.  Then the patient makes a round of the city's pharmacies and with the doctor's list gets whatever is available and then returns to the doctor, who prescribes a therapy with all possible combinations.

Those who have money and do not wish to give up their old therapies and the method of taking insulin, mainly buy insulin abroad or on the domestic black market.  Those with less money make rounds to domestic insulin manufacturers, distributors and humanitarian organizations, while the more choleric individuals, when they are offered by doctors a change of therapy, say that they prefer to die than to change medication.

According to data gathered by the Serbian Institute for Healthcare which includes the last, stressful year we went through, there are over 120,000 diabetics registered in Serbia.  Estimates are that over a third of them are taking insulin.  For thirty years already (since 1970), a law indicates that every diabetic must register with the authorities.

EVIDENCE:  Dr. Ljubinka Marcetic from Belgrade's Civic Institute for Healthcare warns in an interview for VREME that for various reasons not all citizens report their diabetic condition, and she estimates that there are at least twice as many diabetics in Belgrade that data gathered in 1999 indicates, with officially registered 34,773 diabetics in Belgrade.

"Around two percent of the population of Belgrade suffers from diabetes, with only registered diabetics being included in this group.  And while in 1990 we had 122 diabetics for every ten thousand citizens, last year's figures indicate 212 diabetics for every ten thousand citizens.

In Belgrade, women are more prone to diabetes than men: 55 percent by contrast with 45 percent.  The average age of those affected with this condition increased to age 57.

This is the age condition of the population of Belgrade which has grown much older in the past ten years."

Dr. Marcetic points out the significant number diabetics who are included in the death statistics of Belgrade's population: "Two percent of our fellow citizens die from diabetes as one of their diagnosed conditions.  However, another figure is cause for worry: of the total number who died in Belgrade, 13 percent of our fellow citizens died from diabetes as a secondary condition.  More precisely, diabetes accelerates deaths in cases of stroke, heart attack, blood poisoning and kidney failure.  Most of these conditions are in any case side effects of diabetes."

FIFTY BY FIFTY:  "In 1990, 1256 people in Belgrade died with a diagnosis of diabetes.  Eight years later, that figure tripled and quadrupled, and rose to 4696.  This indicates that in Belgrade there is an increase in deaths from diabetes."

Both doctors and suppliers are ready to admit that there is a general shortage of insulin in Serbia, especially of human insulin.  Pessimists assess that real shortages of this medicament will come about in about two weeks, if not measures are taken.  Of the fifty different kinds of insulin, with short term to long term effect, which is the number of registered kinds of insulin on the Yugoslav market, today it is only possible to find, off and on, some ten kinds of insulin in pharmacies, which are mostly from domestic manufacturers or from distributors who packaged themselves insulin manufactured by Hemofarm and Galenika.

Belgrade's pharmacies also confirmed that there is barely any domestic insulin available, that choice has been significantly reduced, and that it is difficult to find substitutes for appropriate drugs, even among domestic manufacturers.  Foreign manufactured insulin has not been available for some time.

What in fact happened?  Cynics would say that what we are already used to merely happened: poverty and the already failed option of improvising, which we have done for the past ten years.  Diabetics are not in a position to improvise with their medical condition.  They have their condition for their entire life, they have their habits, precisely prescribed medication and therapy.  Their serious conditions requires high quality proven drugs, with the choice in insulin treatment and continuing to live ranges from insulin from animals (the best known is pig insulin) to human insulin, which our doctors prescribed and recommended to their patients according to latest research.  With reason, of course.  In the nineties the classic therapy of the needle and the painful piercing of one's body several times a day was largely replaced even here by the virtually painless use of insulin which is especially suited to children and blind patients.  This is the so called pen therapy in which a pen syringe is used.  It can be carried in the pocket and has a precisely determined dosage needed by a given patient.  Therefore there is no needle, there is no measuring.  All together more reliable, humane and precise.  Of course, pen assumes exclusive use of human insulin.

The Dutch firm Novo Nordisk supplied this type of insulin through Velefarm's distribution.  Hemofarm was and still is in charge of importing the Nordisk human insulin.
The insulin supply plummeted significantly last year when the government confiscated Milan Panic's ICN Galenika, having sold it to him several years earlier with considerable pomp and circumstance.

DEBTS:  The story of Galenika is only significant here inasmuch as this once powerful pharmaceutical company supplied our market both with human and pig insulin, and owned the technology for completely purifying insulin.  The technology still exists today, but it appears that the raw materials are lacking.

"While ICN Galenika was still around, it supplied the Yugoslav market, with the cooperation of famous world companies (Hoffman, La Roch and Lilly), principally with pig and then human insulin.

As a manufacturer, we never registered profits in the production of insulin, but we tried hard to supply our market.  On a monthly basis we produced 100,000 packages of all kinds of insulin, not including the pen system.  The market was supplied with 80,000 to a 100,000 tablets for diabetics, Tanja Brkovic, a former director with ICN, told VREME.  (Ms. Brkovic is presently working in Podgorica.)  She also pointed out that when they were forced to leave their factory last February, they left behind raw materials for one year's manufacture of insulin.  With the disappearance of ICN and with the bombing, and with slow payment for delivered raw materials, Galenika's foreign partners also disappeared.

For the sake of record, the government demanded that Hemofarm, which participated around twenty percent in the total manufacture of insulin, fill the shortage of insulin on the local market.  The factory responded by reducing production and the government retaliated by threatening to import insulin.

The biggest supplier of the Yugoslav human insulin market and the only one with the pen therapy is Novo Nordisk of Denmark.  For five years already, Nordisk's official distributor for Yugoslavia is Velefarm, while Hemofarm is the official distributor for human insulin in vials.

Predrag Radosevic and Ratko Miladonovic from Belgrade's office of Novo Nordisk told VREME that insulin is here on consignment, but that it is nor reaching pharmacies because of high debts.  This was also suggested by Velefarm's announcement sent to VREME at our request.

"We really tried to do everything in our power.  Our goods came even during the bombing.  We have been in this market for some time, and during better times, we took care of 50 percent of insulin users.  Velofarm's one year debt to Novo Nordisk amounts to 15 million German marks.  Servicing only one part of this debt would result in the return of our insulin to this market," our interviewees told us.

They do not deny comments by their local partners regarding the high cost of the pen therapy, but is justified by the world market price which is the one Novo Nordisk operates on (Novo Nordisk is otherwise the biggest supplier of human insulin and the pen therapy on the European market).  "The consignment price is around 60 DEM and includes a package with 1500 units of insulin.  The patient needs this amount for around 40 days.

Measured by world prices, bottled insulin here is only marginally cheaper.  One bottle contains 400 units and the patient needs four of them to replace one pen therapy.
Otherwise around 200 people phone in to Belgrade's Novo Nordisk office, asking for insulin and demanding help.

None of the doctors we talked to denied the advancements of the pen therapy.  This is an intensified therapy which simulates as much as possible the physiological release of insulin within the human  body.

Today this therapy is considered the best therapy because it ensure the best glucose regularity which determines the intensity of future complications.  For instance, good glucose regulation postpones loss of vision, of kidney function, of gangrene and similar complications.

Even our neighbors have introduced the use of human insulin and the pen therapy.

TREATMENT AND SIDE EFFECTS:  According to the World Health Organization, even Albania is no longer using animal insulin.  Bulgaria will soon discontinue its use, while Rumania will do so at the beginning of next year.  It is no longer available in Bosnia or Macedonia.

In its health policies the world starts from the position that the best therapy for diabetes is cheaper than the consequences for health which can result from not using it.  Diabetes is a very common condition around the world.  For instance, in the USA around ten thousand people suffer from diabetes.  Experts with the World Health Organization calculated that only three percent of the total money spent on health is used for diabetes therapy, while as much as 60 percent is used on treating the effects of inadequate therapy.

"There is no doubt that the administering of insulin with the pen is first of all a lot easier for patients, and far more important is the degree of accuracy achieved using this method.  We recommended and gave it to patients on every occasion as a system of modern therapy.  And it worked," Dr. Mirjana Dragasevic of Belgrade's Institute for Endocrinology stresses.  She warned that a shortage of this therapy threatens patients who are using the so-called intensive therapy.  "These young patients and pregnant women to whom it is impossible to give insulin four times a day using old syringes and needles.  Furthermore, there are blind patients and babies.  They will simply go without the use of a modern therapy.

There are established indications for the use of certain kinds of insulin on the basis of which doctors prescribe insulin to patients."

When we asked whether it is possible to replace one type of insulin with another, Dr. Dragasevic told us: "In the absence of one kind of insulin, a substitute can be used, but under such conditions we must take into account the braking of established doctrines which we achieved in the use of world medical standards in this area."

TV THERAPY:  Doctors agree that reverting to insulin from pigs and to the classic needle is a step backwards in the treatment of diabetes.  But to remain alive, a substitute must be used.

A new therapy presumes new, complete education of the patient suffering from diabetes.  Can anyone estimate how much strength and energy will be required by diabetics who are using the intensive therapy (some 15 to 20 percent), and how much their doctors will require to begin from scratch, both with regard to modifying their insulin dosage, as well as to again use syringes and needles.  All in all, it amounts to reverting to a treatment of some twenty years ago.

Few people are willing to speak publicly about the insulin problems in Serbia.  In the past ten days we did not manage to find anyone to talk to in the Fund for Social and Health Insurance which is in charge of how money for healthcare is distributed.

Dr. Teodora Beljic, President of Belgrade's Society for Fighting Diabetes, has already began educating diabetics across state TV on how to adapt to the new conditions of treatment.  We found this personally from her when we asked her for an interview.  She told us to watch Radio Television Serbia, and here is what we heard:
"Today only highly purified insulin is being used throughout the world: this includes SPP pig insulin and HM human insulin.  We always tell patients to read instructions.  Those who previously used human insulin with the pen therapy can change to human insulin in vials using the same dosage without any problems.  If no human insulin is available, they can change to SPP insulin.  There is a small percentage of patients who cannot do this.  Such patients have allergic reactions; furthermore we always say that there must be human insulin available for children and for pregnant women.  Why?  It is stronger and a smaller dose of insulin is required to achieve the same effect.  Everyone else using human insulin can change to highly purified pig insulin, although they will need to change the dosage.  Not every syringe is the same, nor is every vial the same.  If someone has old supplies, they must be aware of the fact that they cannot use the insulin which is used in the pen therapy, now in a syringe, because this could have unpleasant consequences.  I repeat once again, there is no problem in changing from the human insulin to the pig insulin."

Other doctors we spoke to we not quite as specific as that.  One of them told us that diabetics are a high risk group whose response is difficult to predict.  Furthermore, the consequences of inadequate therapy might only show up later.

When one year ago Hemofarm entered into battle with the government and the Fund, it became clear that after the problems with Galenika, this successful company will have to take on all the weight of our poverty.  The Fund does not permit an increase in prices, and according to the present conditions and costs it is impossible to produce them without a loss.  Our impoverished healthcare is not in a position to pay back manufacturers and distributors even the medication which has already been manufactured and is being sold.

Where human insulin is concerned, the circle is closed: Novo Nordisk, which covered nearly 90 percent of the Serbian market, is owed enormous amounts of money by its Yugoslav partners and distributors.  The Fund for Social and Health Insurance, in turn, owes them that money.  All the people who owe money to the Fund are impossible to enumerate.  In any case, the policy of a vial of insulin for two German marks in the interest of civic peace has proven untenable.  When the price for behaving this way with diabetics finally comes, other patients will also be in line.  Doctors are keeping silent, the government is promising Chinese insulin instead of doing its job of respecting what it has decreed.  It has regulated the healthcare of 120,000 diabetics, among others, by law.  And all out of its pocket.  In the past years the government merely managed to strike fear in diabetics with the shortages of drugs without which they cannot live, and managed to completely confuse them to a point that from all the trees, it's impossible to see the entire forest.

Caption

Announcement

Belgrade's Velefarm which sells, distributes and imports medical drugs is in a business partnership with Novo Nordisk, a well known world manufacturer of human insulin for the so-called pen-therapy.  When we asked them why there is no foreign human insulin in pharmacies and whether there will be any in the near future, they responded with an announcement which we are publishing in its entirety:

- There is no Novo Nordisk insulin in pharmacies because the supplier is owed substantial amounts of money.
- During  1998 Velefarm supplied 619,000 pen insulin packets of 100 IJ or around 190 million insulin units of actrapida, insulatarda and mixtarda.
- The arrival of Novo Nordisk insulin on our marked exclusively depends on when the money owed to this supplier is paid.

In Belgrade, 27.3.2000.

Testimonies

M. M. from Belgrade, mother of a boy who suffers from diabetes, has been striving to have her child treated for six years. This is her testimony about what it means to fight against illness at this gloomy and unfortunate time: the supply of medications which are always lacking, food, treatments, life between fear of future and desire for normal childhood of her child.

'He became ill in his 15th month. And we have been living with it for six years - with insulin ever since the first day. You've got to have supplies of all those things necessary for everyday treatments, since you never know when you will be lucky to find a proper medicine, injections, or other things at the chemists'. Much of these things are needed every month. The insulin can only be bought with a prescription, but it simply doesn't exist. Since the beginning of his illness, our boy has been using a combination of human insulin produced by 'Galenika' in association with an American company 'Lily'. It has, at least, been until now. We often coped with it by finding some links in 'Galenika'. The child still consumes smaller dosages, so the consumption is not that extensive. The chemist's shops still do not sell those items. It is far from simple. We have to combine and dose up the medicine according to the need. Now I'm already experienced in it. It was much more annoying before. I had nightmares. I would wake up at night, asking myself whether I gave him the insulin and when. Those were different periods that people sometimes have to go through.

We would have not been able to function without a device for controlling the level of sugar, which we use three to four times a day. And that also costs a lot. Only the control strips cost us about 200 DM per month. The social security refunds it, but only after two or three months. Thus, at the beginning of each month we've got to have money prepared for medical treatment. The additional problem is that even the strips are no longer easy to find at the chemists'. Many parents with modest financial income are not able to do that. Some of them are used to the situation and start taking it for granted.

It is also difficult with syringes and needles. During the last six years, I have never managed to find them at the chemist's shop. Those are special insulin syringes with micro fine needles which make the usage less painful, and that can be very important if you have to apply the insulin four times a day.

I once bought them in a firm which used to import them. When I showed the bill to the social security, they refused to refund the expenses. They say that they do not refund the costs for needles. Then, how shall I apply the insulin? With fingers? I stopped trying to get a repayment. However, it is a minor aspect in the whole story. Everyone copes in their own way. There is not enough insulin, especially not the human one. A few days ago, I searched the entire city and found only a single ampulla, and its shelf life has almost expired. I did not buy it, since I could not use it before it completely expired. Maybe it would be of essential need to someone else.

In the beginning I tried not to buy my son special crackers and chocolates for diabetics. When I realised that our child would look at others eat sweets, we started buying those things too. Above all, we have to buy them abroad, because they cannot be found here. And that is very expensive. One chocolate for diabetics is worth as three normal chocolates. In order to avoid having different food in our plates, we made a compromise: for lunch - we all eat the same dish, but for other meals - the child's dishes consist manly of integral cereals.

Unfortunately, many people cannot afford to treat their sick children in this way. The situation is like this: those who are able to buy all that is necessary for a full treatment, are in a situation to be in contact with those people who can provide them with whatever they need. The poorer ones have no one who could supply them with those indispensable things. And this illness is not something that can be treated from today until tomorrow. It lasts forever.
The doctors tell you what you should use, and it is up to you to deal with the situation.'

Pharmacists without Boundaries

Ragu Kumar, a Pharmacist from India

'Pharmacists without Boundaries are a humanitarian organisation and, in Yugoslavia, they work on the project of medications in short supply, regardless of whether they are produced in domestic factories or not. We devoted some attention to those chronically ill patients, which have been endangered for a while for not being able to get hold of necessary medications. It was difficult to determine the right criteria, considering the fact that a great deal of medications are in short supply in Yugoslavia. We estimated that insulin is one of the priorities.

Along with the insulin, we opted for anti-asthmatics in the form of spray

and pump, intended for those suffering of chronic asthma. We also included the neuroleptics.

We gave priority to those types of insulin which we distributed to 15 towns of Serbia and to all state chemist's shops in Belgrade. We chose two types of insulin: the first type produced by Nordisk and the second type, produced by the local factory called 'Hemofarm'. They all have different effects. Before anything else, we visited various chemist's shops and hospitals, then we spoke to a number of pharmacists and doctors, and we finally decided on the choice of priorities regarding the locally-produced insulins. As for the imported ones, the situation was different. We also acquired a considerable quantity of needles and syringes.

Our idea was, though it was not under our jurisdiction to decide where they would be distributed, to intend the imported insulins (due to their smaller needles and a less painful way of application) to children and to elder or blind diabetics. We succeeded in that in Sombor. In normal conditions, it would be good to treat all patients with these insulins, but it is not so. The insulins produced by 'Hemofarm' were not human, they did not have them available at that moment. So, we bought human ones from Nova Nordisk.

We labeled all the packages with labels from our EU sponsors, as well as with a humanitarian aid mark and a notice that the medicine is free of charge and can be collected only with a prescription. We also took names and identity card numbers from all patients who collected some medications.

Some sorts of insulin were distributed within several hours, and we were not surprised because they are not accessible on the local market.

It is interesting that the insulins were situated in 'Velefarm', in a state pharmacy, they were on consignment.

This month we had two deliveries. Before that there was another in February. If the financial situation makes it possible, we will increase the quantity of the most requested types of insulin.

Some patients are supplied for a longer period of time. We also distributed a number of needles and syringes from 'Hemofarm'. In Sid's hospital, they told us: 'Thank god that you came, we almost ran out of insulin.'

The doctors are warning that the number of diabetics has much grown lately.

With the arrival of refugees from Kosovo, the number of diabetics, especially children, is constantly increasing.

Diabetes is not an illness, but the state of an organism, and as less painful as possible treatments should be provided for those who suffer from it, particularly for children. We are not in position to supply everyone with needed medications. Considering the situation, we shall base the future distribution of humanitarian aid on the insulin therapy.
The program of hospital aid also included the donation of X ray films, developers and fixers, as well as medication for the treatment of schizophrenia.'