Liepāja hospital accused of placebo research without consent

Take note – story published 1 year ago

A patient at the Liepāja hospital has received a placebo medicine intended for participants in a clinical trial without the consent of the patient or their family, Latvian Television reported on June 12.

The hospital management has promised to investigate this situation, but the patient's relatives indicate that they are speaking publicly in order to prevent such cases in the future.

Three weeks ago, a relative of Karina Kalerija Kostrjukova, arrived at the ICU of Liepāja Regional Hospital with heart failure. Karina, who, had spent time in the hospital with the severely ill relative, decided to look at the dose of one prescribed drug. But she also saw unexpected information.

“It's a label I removed from the albumin bottle, which was administered intravenously to my relative. On the label of this bottle, however, it appears that this is a “placebo” medicine. This means that this medicine can only be used in a clinical trial. And the medicine expired on May 1,” she explained.

Karina Kalerija Kostrjukova is a docent at the Rīga Stradiņš University. It is clear to her that her relative should not have received such a medicine.

"No one was informed that our relative would be included in the study or in general that he was given a medication that is at the stage of research. It is possible that we would agree if we had this information," said the woman, expressing awareness that doctors, on the one hand, try to do their best, but on the other hand, this is a drug from a study, and with an expired expiry date.

Kostrjukova points out that the agreement with the hospital signed by the patient in the ICU, likely without even knowing the content of the contract, does not indicate such practices either.

Patient rights defender Solvita Olsena said out that in the described situation there are a number of red flags indicating a potential violation. The first was the hospital contract signed in ICU.

"A person can sign contracts and make any commitments only if he understands it well [..]. These practices should be stopped both at Liepāja hospital and in other hospitals," Olsena said. "No medicines should be administered which are not properly approved for patients who are not participants. And it is clear that all drug substances have expiry dates. No medicinal products should be taken after their expiry."

Liepaja Regional Hospital indicates in a written reply:

"We have also been in contact with the patient's relative and apologize for the situation. During the tests, the medicine received has not worsened the patient's health status.

"Clearly, such a situation in which the medical authority infringes the procedures for the circulation of medicinal products is unacceptable. Initial information has been received from the medical practitioners involved and work is being carried out on the assessment of the situation in order to prevent the recurrence of similar offenses in the future."

Karina Kalerija Kostrjukova's family has received an apology, but she plans to inform the Health Inspectorate and the Latvian Medical Association about the case. They point out that the situation was accidental, but the family wants to be sure that these situations will no longer be repeated.

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