How an Extremely Serious Disease Is Treated in Romania: Salvator Serum, Unable to Find in the Country Because It Expires in Stock. “We Were Supplying From Russia Until Recently”

The doctors from Ploiești asked for help from their colleagues in Chisinau, where they received two doses of the necessary serum. On Tuesday, April 23, another dose was requested also from the Republic of Moldova, the patient’s condition being improved, but still critical.

The man diagnosed with this rare disease began to have digestive symptoms (bloody diarrheal stools, vomiting, later constipation) on April 10, 2024, but he presented himself at the Urlați City Hospital only on April 12, when his state of health improved seriously altered.

He began to show neurological symptoms, namely visual disturbances or lack of appetite, according to a press release from the Public Health Directorate (DSP) Prahova. He received symptomatic treatment but to no avail, which is why he returned to the same hospital on April 16, 2024 in an even worse condition.

On April 17, 2024, he was transferred to the infectious diseases department of the Emergency County Hospital “Dr. Constantin Andreoiu” Ploiești, where the on-call infectious disease doctor raised the suspicion of botulism. The man already had obvious neurological symptoms, says DSP Prahova: palpebral ptosis (no – drooping eyelids), mydriasis (no – pupil enlargement), swallowing disorders (no – difficulty swallowing).

The man stated before the attending physician that, on April 9, 2024, he consumed two cans of fish in oil by himself.

On April 23, medical tests confirmed the presence of botulinum toxin, according to a press release from DSP Prahova.

What is not mentioned in DSP Prahova’s information is the complicated way in which the infectious disease doctors managed to obtain treatment for the patient on the verge of death.

In Romania, there is usually no antibotulinum serum in stock, and the hospital in Ploiesti was forced to ask for help from colleagues in the Republic of Moldova. The information was confirmed for Libertatea newspaper by the doctor Andrei Ilinca, spokesperson of the institution.

“We made a request at the national level for this botulinum antitoxin, but it is not found in Romania. As far as I understand, there is no longer a marketing authorization in Romania. I don’t know why,” said Dr. Andrei Ilinca.

On Tuesday, April 23, the infectious disease doctors from Ploiesti considered that one more dose of antibotulinum serum was needed and made another order in the Republic of Moldova. The treatment was to be brought to Romania with the help of the Directorate for Emergency Situations (DSU).

“We source from Russia”

The absence from Romanian hospitals of this vital serum in the case of patients diagnosed with botulism was confirmed by infectious disease doctors from Bucharest and Timișoara, being a well-known situation that has been going on for years. The doctors in the territory are forced to “fake” a treatment, to ask for help from the big hospitals in Romania or, as happened in the case of Ploiești, from outside the country.

“We had four cases of botulism, quite recently, a few months ago, a familiar outbreak. The hospital had a few vials, and I got the rest through DSP, the serum was Polish. Usually the ministry (no – Health) makes the order and then the hospitals are supplied according to their needs. We were getting our supplies from Russia until recently, but since there are problems, a similar serum has been found in Poland. Because they are quite expensive, the investment is quite high. If you don’t have cases of botulism, it expires, and this is a budget problem,” explained Dr. Virgil Musta, head of department at the Dr. Victor Babeş Clinical Hospital for Infectious Diseases and Pneumophthisiology in Timisoara, for Libertatea newspaper.

The lack of antibotulinum serum is also confirmed by Cătălin Gabriel Apostolescu, director of the Matei Balş Institute in Bucharest.

“The antitoxin manufacturer’s marketing authorization has expired. He has the obligation to take all steps to obtain authorization. He knew that the permit was for a certain time and he had to do all his paperwork in time. It is well known, both the problem with botulinum antitoxin and with tetanus antitoxin. It has been for years. We patch up like this for a few months, a year, then the story repeats itself and so on. It’s a national situation,” said Dr. Cătălin Gabriel Apostolescu for Libertatea newspaper.

“If he’s lucky enough to have a small amount of the toxin, he escapes”

The serum that is missing from hospitals in Romania is vital for patients diagnosed with botulism. Although they are rare cases, with up to 20 confirmed annually in the last four years nationwide, these people are at risk of death if they do not receive the antitoxin immediately.

In addition, the serum does not cure the damage done by the toxin in the body, but only stops the progression of the disease, so it is important that the patient receives the treatment as soon as possible.

“This disease, if you do not treat it with serum and the patient develops a severe form, is fatal. If he is lucky enough to have a small amount of toxin, he escapes. We have had patients who escaped without taking the serum, but we have an obligation to stock up and have it in stock just so you can cope at least initially.

It is a fatal disease. It is not really diagnosed, because some clinical manifestations must appear, otherwise you have no way to think about botulism. It is diagnosed when the first neurological symptoms appear, with palpebral ptosis muscle paresis, dry mouth, blurred, double vision. When such signs appear, patients present either to an ophthalmology service or to a neurology service, because the symptoms are more characteristic of these specialties. There they are diagnosed and sent to us.

They rarely arrive directly (no – infectious diseases ward). But the severity of the disease is directly proportional to the amount of toxin ingested and the time that passes from the onset of symptoms to the administration of treatment. The treatment must be administered early”, Dr. Virgil Musta explained for Libertatea newspaper.

“They looked a little at the cans, that they should not be bulging, that they should not be rusty”

After the man from Urlați arrived, on April 17, at the hospital in Ploiesti, the doctors informed the competent authorities in the county about the suspicion of a case of botulism, adding the data provided by the patient regarding the possible source of the infection – the canned food that he claims that he bought it from the local Lidl supermarket and that he ate it before the first symptoms appeared.

According to the medical authorities involved, the man could not provide the name of the product, saying at the hospital that he vaguely remembers that the can in question had “a yellow band” on the packaging.

On April 18, DSP inspectors went to check the Lidl store in Urlati “without finding any hygienic-sanitary deficiencies”.

Also on April 18, 2024, after the control, DSP Prahova sent an information to the State Sanitary Inspection within the Ministry of Health and to the Veterinary Sanitary and Food Safety Directorate (DSVSA) Prahova.

DSP Prahova officials used the channel of the Rapid Alert System for Food and Feed (SRAAF), a tool designed to urgently transmit information to all European Union states in the event of a severe public health risk being identified.

The alert from Prahova, however, stopped at the level of the central and county authorities “due to the lack of elements to identify the suspect food”, says the DSP.

County inspectors from the Veterinary Sanitary Directorate also went to check the Lidl store.

“We were informed. There are alerts on the rapid alert system from the Directorate of Public Health. The patient with confirmed botulism said he had eaten canned goods. Where from? I do not know! What cans? We do not know! There were also my colleagues, there were also those from DSP. They checked the cans. They found nothing. It can also be from people’s homemade preserves. He (no – the patient) says he ate sardines. I went and checked at that store where he stated he bought the can. They looked a little at the cans, that they should not be bulging, that they should not be rusty, because otherwise you have nothing to do…”, said Gheorghe Stratulat, head of DSV Prahova.

The DSP-DSV joint investigation did not reveal, in the end, the source of botulism infection of the man from Urlati.

The representatives of Lidl Romania, in their turn, sent a point of view regarding the situation reported in Urlați. “We are very sorry that a person is going through such a situation and we wish him a speedy recovery. The safety of our customers is fundamental to our business.

Until now, Lidl Romania has not received any notification through the Rapid Food Alert System regarding a product sold in our store network.

At the same time, we mention that on April 18, 2024, two checks were carried out at our store in Urlați, by the competent authorities of Prahova County, and no connection was established between the condition of the person from the Emergency County Hospital in Ploiești and a marketed product in our store network”, the Lidl Romania press release states.

“We’ve had botulism patients from smoked sausages”

Infectious disease experts state that a consumer cannot detect botulinum toxin in a food product, as it does not have a specific shape or smell. They advise us to avoid eating the food if the jars or cans in which it is stored look suspicious, are damaged, cracked or swollen.

“Suspicious cans should not even be opened, smelled, touched, and the food in them should not be eaten. Also, food that has an inappropriate smell and appearance, for example with liquid or foam, must not be consumed under any circumstances”, stated the experts from DSP Prahova.

Doctor Virgil Musta explained that botulinum toxin is not only found in canned goods, but also in home-made products.

“We have never had canned botulism, only one case from a home-made canned food, instead we have botulism from products that were smoked. By smoking, they were prepared in an anaerobiosis environment, in an environment contaminated with such spores. We have had patients with botulism from smoked sausages, from ham, from these sausages prepared in the household”, according to the doctor.

In a report by the National Institute of Public Health, in 2018, 24 suspected cases of botulism were reported in Romania, of which 15 cases were confirmed. The number has remained constant in recent years. According to some medical sources, 15 cases were confirmed in 2023, and in 2024 we have, so far, 13 illnesses.

Illustrative photo: Shutterstock

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