The head of the pediatric oncology department of the city hospital N31 of St. Petersburg, Doctor of Medical Sciences Margarita Belogurova , told Olga Allenova why new generics are not used in her department and what needs to be done to ensure that new drugs receive the approval of doctors.

Is replacing original drugs with generics in oncology a big problem?

We have nothing against generics. There are good generics, we know them, we have been working with some generics for many years. But the decision about which generic can be used to treat a patient should be made by the doctor working with patients, and not by an official. This is a choice based on the experience and knowledge of the doctor.

There is nothing wrong with drugs becoming cheaper if these drugs are of the same high quality as the original ones. But the problem is that not all generics are of high quality. And in Russia there is no control over the quality of these drugs.

Why aren't all generics high quality?

I repeat, the point is not that we don’t like generics; there are also original drugs that are not of very high quality. But look at how the medicine is being produced. The manufacturing company finds the molecule, the formula of the active substance, conducts clinical trials, and proves the effectiveness of the drug. Then its safety and dose tolerance are checked - and the drug enters the market under its commercial name. But it has a chemical formula - an international nonproprietary name, the very active substance that is active in this drug. In addition to this active ingredient, the ampoule or capsule may contain a dozen other additives.

When the patent expires and the company sells its invention (and it is often simply obliged to do this), the active substance ceases to be its exclusive and it is obliged to discover its chemical formula. Another company picks up the idea and says: we will now produce this. But they will already produce a generic. And no one knows what they will add to the capsule to the main active ingredient. After all, the company that developed the drug is not obliged to reveal the composition of all the additives that were in it. She is obliged to discover only the chemical formula of the active substance.

This is where all the problems come from. Manufacturers say: “This is the same active ingredient - both in the original drug and in the generic, how can a generic be bad?” And the officials nod their heads: “Yes, of course, these drugs are identical, but the doctors are simply corrupt, they receive a percentage from the sales of the original drugs, and so they rebel.”

And no one will bother to conduct clinical studies and find out what is actually mixed into the capsule except the active substance. There are ingredients that either cause a toxic, allergic reaction, or reduce the effectiveness of the active substance itself. It's just a different drug.

But officials don’t understand this. When an official sees that the drugs have the same active ingredient, but the packaging of one costs 2 rubles less, he wants to buy the one that is cheaper. Companies producing generics take advantage of this, reduce the price, save on research and quality control.

How do we purchase government drugs? We need such and such a drug, there is an auction going on. Companies come, offer based on the principle of “who is cheaper” and win. There is no production control. Maybe they will launch a good first batch of the drug, and then, when they conquer the market, they are already knee-deep in the sea. It’s like in construction - they come, give a low price, win the auction, and then respond to complaints: “What did you want for that kind of money?” This is just hand-wringing. Today there is a pursuit of profit. In this situation, drug purification and quality control are not in first place, but in last place.

The pharmaceutical business is now second in the world after weapons and drugs. That's why there is such a struggle.

And okay, producers, but officials! They do not calculate the cost of treating the complications that arise as a result of taking these new drugs. And they don’t understand that in the end it will be more expensive for the country.

Do I understand correctly that it is not the generics themselves that cause concern, but the fact that from July 1, according to the new law, the doctor will not have the right to choose a drug for a patient by trade name?

Exactly. Now we will not have the opportunity to work with high-quality drugs if they cost 10 rubles more. And no one hears us. They say: “Oncologists are corrupt, they are bought by manufacturing companies.” We recently asked at a city meeting to leave original drugs at least for children, but they told us: “Well, it’s clear why you stand up for original drugs, you have your own interest there.” So, in order to remove this reproach, I declare: we are not against generics, we are against drugs being replaced without the knowledge of doctors and without consultation with them.

We want to treat with drugs that have known efficacy, predictable toxicity, and guaranteed safety. We are not talking about a high-quality or low-quality drug - even the highest quality drugs can be toxic. And it happens that toxicity is an integral part of treatment. We are only talking about the fact that we have worked for many years with drugs whose effects we know. And we should have a choice - to prescribe these original drugs or generics. Because when we have toxicity as an indispensable part of treatment, it’s one thing, but when we get toxicity in addition to treatment, which should not be there, that’s completely different.

I am now talking about drugs that have the same effectiveness, but different toxicity. What to do with those drugs where the effectiveness is different? Who knows what was mixed into these analogue drugs if their production is carried out at an enterprise that does not meet the parameters of GMP (Good Manufacturing Practice - a system of norms and rules regarding the production of medicines developed in the European Union. - "Power" )? If a medicine production does not have this certificate, we are not ready to work with it.

Does anyone in Russia have this certificate?

No, in Russia none of the drug manufacturers have such a certificate. If you are in this system, then there is always strict control, constant international commissions, inspections, at least once a month. Because they give a certificate, which means they are responsible. But we are afraid of these checks like hell. And therefore our manufacturers do not receive a certificate.

So this international certificate is the only proof of quality?

Not at all. If Russian manufacturers are categorically against receiving this certificate, then let them prove in clinical studies the effectiveness, non-toxicity of the generic and its identity to the original drug.

The drug may be bioequivalent to the original, but due to the synthetic components mixed in the capsule, its effectiveness may be reduced. In oncology, we cannot take such risks: if a drug is ineffective, we will not know about it immediately, but after several years. We treat and summarize the results every five years. If we start using new drugs, we will understand how they work only in five or six years - when we see how many children have died, how many relapses and how many remissions.

Why can’t we immediately understand that the drug is bad?

If the drug's effectiveness is poor, but it is there, the child will go into remission, and then a relapse will occur. But how can we immediately prove that the relapse occurred due to the use of a not very good drug? Relapses happen even on good medications. We will be able to understand that this drug is ineffective years from now, when people look at the statistics and calculate how the rate of relapses and deaths has increased with it.

If our officials claim that generics are the same drugs as the original ones, let them authorize clinical trials. These studies can be carried out throughout the country at once, and it will not require much time - just money. But we have money in our country, and we should not save money on the health of our population. But again, these studies will only show the level of toxicity, and the effectiveness can be assessed much later. To ensure the high effectiveness of these generics and to recommend their use instead of original drugs, long-term observation of patients is necessary.

But manufacturers and officials do not undertake such research - apparently, they are afraid of the costs. And without research, we shouldn't agree to use drugs we don't trust. If someone takes responsibility for the life and health of patients, it is on his conscience. I can't do this.

I believe that a generic drug should be approached from this position: it is a different drug, different from the original one, and its prescription to a patient should not be based on the INN (International Nonproprietary Name - “Power” ), but on the basis of its trade name.

Do you work with new generics in your department?

In oncology, we only work with drugs that we know. Even if these are generics, we have known them for a long time. Because we already had an unpleasant incident with the use of a new generation generic. A girl from the region came for treatment, her treatment was paid for, we wrote out a treatment regimen for her, her mother went to the pharmacy and bought drugs, but one drug was not original, but a generic, the pharmacist at the pharmacy told her that it was the same as the original , only cheaper. The girl is being treated, the doctors call and say: “We don’t understand what’s happening, the child is very bad, she has a fever, and next to her lies a second child who has the same treatment, and everything is fine.” It’s good that they realized it in time and checked the packaging of the drugs. And it became clear that the child reacted so negatively not to the active substance, but to synthetic additives.

In your department, you recently had a case of an allergic reaction to a generic drug in a child.

Yes, but these were non-oncological drugs. Our resuscitators took propofol instead of diprivan and administered it to the child to perform a minor operation. This girl was treated with us for many months, she had a brain tumor, she was given a special catheter under the skin - a “port” to continuously drip medicine. The girl was cured, the tumor disappeared, the catheter had to be removed. And then the drug is administered to the child, she stops breathing, goes into anaphylactic shock and almost dies. The catheter was not removed, the child was pumped out. Then she was treated for three months with hormones for a severe allergic reaction - she developed bronchial obstruction, that is, bronchial asthma. The girl’s parents conducted a basophil test in the laboratory of the Ministry of Emergency Situations: she was injected with microparticles of both drugs, diprivan and propofol, to understand which drug causes the allergic reaction. On Diprivan the indicators turned out to be normal, but on Propofol they were 2.5 and 6 times higher than normal. We are very grateful to these parents, because as a result of their research, we have a document in our hands that allows us to refuse the drug propofol. But not every parent will go for such research - it takes time and money.

Why did your resuscitators take the generic?

They don’t ask us when they buy drugs. We have long been forced to write in orders not the commercial name of the drug, but the INN. Our pharmacy did not have diprivan, there was propofol. Previously, resuscitators had no complaints about propofol, so they took it.

You said that in your department you do not use new generics in treating children, but are they already treating adults with them?

Adults are being treated, as well as children in the regions. Our colleagues in the regions are suffering; it is difficult for them to prove to officials that the original drug and the generic with the same INN are still different drugs.

I remember such an incident. In the early 1990s, we began working with the drug asparaginase - Riga and German. Riga was then in the USSR, and drugs were cheaper there. We gave several bottles of the Riga drug to our German colleagues for research, and it turned out that the active substance, even in volume, differed from bottle to bottle. Plus impurities of heavy metals. And the Germans then told us: “This is not the same medicine, this is a different drug.”

You said that if new drugs pass clinical trials, then you are ready to work with them. How are such tests organized?

There must be a comparison: here is the original drug, here is the generic. We evaluate efficacy, toxicity, and tolerability. One group of patients is given the original drug, the other is given a new one.

What if patients start dying?

No one will ever bring it to this point. The very first toxic reaction will be a “stop” signal. If five people showed a high toxic reaction, then the drug should be closed. But this must be done immediately and throughout the country. If officials and manufacturers are not ready to do this, then the topic of replacing drugs should be closed.

How do you avoid changing medications in your hospital?

We are only succeeding so far. But from July, when doctors throughout the country will be required to write prescriptions by INN, and not by trade name, I don’t know what will happen. No doctor should break the law. This means prescribing medications to patients that you are not sure about. I don't know how to solve this dilemma. And then, today original drugs are available in pharmacies; our hospital pharmacy can purchase them. But if they disappear from the market, where will we get them?

Why should they disappear from the market?

This will happen if contracts with manufacturing companies are terminated. Any drug must be registered in Russia, in Rospotrebnadzor, the contract has a period of five to six years. If they don’t want to conclude a new contract with the company, it will leave. Why enter into an agreement with her if her drug has been replaced by a cheaper and more profitable one? And why do we need competition if we have a domestic drug? And people won’t even be able to buy this original drug for money, because it will simply disappear from pharmacies. This is too high a price. People need to be treated with the best that is available in the world today.

"It's just hand-wringing"