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Illegal medical experiment at Dutch psychiatric clinic

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Nurses at ‘GGZ Noord-Holland’, a psychiatric clinic in the Dutch town of Heiloo strongly believe that large errors have been made in a scientific medical trial with psychiatric patients who have severe psychosis. The Dutch investigative journalism television program ZEMBLA has an extensive dossier which shows that that according to an internal whistleblower 22 of the 52 subjects had never been allowed to participate in the experiment. The study is therefore infringed by the clinic. Only a year after the start of the study were, at the insistence of the whistleblower, relatives of the subjects by the clinic informed about the experiment. The whistleblower who reported these matters to the Board of Directors of GGZ NHN is fired. She has, on pain of heavy fines, been imposed a gag order. The experiment concerns a combination of two drugs: clozapine, a strong antipsychotic, and memantine, a drug used by patients with Alzheimer’s disease.
According to the study, which was approved by the Medical Ethical Committee (METC) in Alkmaar, only ambulatory patients should be used for the experiment. This means that patients who are admitted to the mental institution should not be included in the experiment. Only trial subjects living independently outside the clinic are allowed to participate.
At the Columbia University, New York, professor Paul Appelbaum, has done much research into the conditions for medical research with psychiatric subjects. In ZEMBLA, he speaks of a "serious breach of the protocol."
Appelbaum: "The change from outpatient to inpatient is a big step. Hospitalized patients are much sicker, much more limited and have less skills to make choices. So that is a big change of the protocol, which surely must be approved by the medical ethics committee."
Documents from the mental institution show that 52 trial subjects were used. Only 30 of them are ambulatory and independent living.  However, the remaining 22 patients are non-ambulatory and are receiving a lot of care in the clinic, eight patients even 24 hours a day. Especially with regard to this group of non-ambulatory patients the whistleblower and other employees at the clinic had serious doubts about their mental competence.
To deviate from the protocol without the consent of the METC is, according to a former professor of Health Law Frans van Wijmen absolutely forbidden, "Then you act in violation of the law, which may be a crime where you might be prosecuted for."
Van Wijmen has been a member of an medical ethics committee for years, evaluating and judging experiments with human subjects. "There is a deviation from the protocol, that is absolutely clear. It can be caused by opportunism, of one’s thinking: it seems to me better to involve the non-ambulatory patients as well, because by doing so I’ll quickly reach my numbers, " Van Wijmen says.
ZEMBLA speaks with relatives of two subjects. They are shocked that they were only informed a year after the beginning of the experiment, because they have serious doubts about the mental competence of their relatives.
For conducting medical experiments with human subjects, scientists are committed to strict rules. The Royal Dutch Medical Association has developed a guideline by which the mental competence of subjects has to be determined.
Psychiatry Professor Jim van Os: "To determine one’s mental competence is always a gray area, which cannot be done by only seeing the patient. To control this gray area, you have to involve the trial subject’s family and nurses. This is part of the roadmap of the Royal Dutch Medical Association. "
The roadmap of the Royal Dutch Medical Association is written by a team of lawyers and psychiatrists led by former Professor Frans van Wijmen.  The roadmap applies to all doctors in the Netherlands. Van Wijmen: “Those close to a patient are very well aware of the ability of a patient to say yes or no."
Fearing reprisals, the nurses would not be mentioned by name in the ZEMBLA broadcast. They have been threatened by the clinic to be fired if they would speak to the ZEMBLA journalists.
GGZ NHN did not respond to the questions ZEMBLA presented to the institution. It only states that the trail was conducted very carefully.
Only after the whistleblower raised the alarm to the matter, the responsible psychiatrist consulted with the METC to modify the protocol. But because the experiment already ended, authorization is no longer on the agenda, Gavin ten Tusscher , the METC’s president, told ZEMBLA.
In August 2013, the medical experiment of GGZ NHN began. It focused on an combination of drugs, clozapine and memantine. Clozapine is an antipsychotic used by severely psychotic patients. Memantine is used in the Alzheimer's disease, in order to prevent memory loss. GGZ NHN hopes the addition of memantine shows positive effects in psychiatric patients who have not benefited from the use of clozapine. In addition, the experiment should show whether this drug combination is safe.
The medical examination within GGZ NHN is performed by psychiatrist Selene Veerman. She wants to promote on this research. Despite several requests from ZEMBLA to be interview, she categorically refused. Her supervisor, Professor of Psychiatry Lieuwe de Haan of the Academic Medical Center in Amsterdam, says that only a mistake has been made with the inclusion of non-ambulatory patients in the study: "The hospitalized patients were operated by the same teams who are also taking care of the outpatients. Therefore they were  added to the study,” De Haan says.

But former Professor of Health Law Frans van Wijmen thinks otherwise: "That's not the point, you should see whether the patients receive 24 hours or shorter time under treatment in the institution. These patients cannot be called ambulatory."

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