Good Clinical Practice Dan Weiss and GCP

Fuad Almaweri

We can summaries GCP violations or misconducts in Dan Markingson death in three main

categories: inadequacy of the informed consent, conflict of interest and negligence in multiple

levels.

Inadequacy of the Informed Consent

Informed consent is more than a signed document, it is a process in which the recruiter provides

the subjects with written materials, verbal instructions, and answering all their questions and

concerns. As well as measuring their understanding, by asking them to explain the process to the

recruiter in their own words.

Giving the symptoms Dan had the moment before enrolling in the study, it is very clear that he

was vulnerable subject, mentally unstable (signs of paranoia and delusions), under stay of

commitment, destitute and was not capable of giving uncoerced informed consent.

The investigator misleads the IRB that Dan is capable of consenting, and that Dans case

manager already agreed to enroll Dan in the study.

Dr. Olson told the IRB that any human subject would have an advocate during the consent

process, there was no advocate with Dan and his mother was against his participation.

Dr. Olson delegated the consenting process to unqualified person and failed to provide her with

enough training and supervision.

Conflict of interest

If an investigator is also the personal health provider of the potential research participant, there

may be an additional conflict of interest. NIH website.

Dr. Olson not just does not know the term therapeutic misconception, he was working as Dan

primary physician and the study principal investigator, which prevented Dan from getting second

opinion or other alternative standard of care. The investigator used the stay of commitment to

enroll Dan in his study rather than giving him the standard of care, and failed to examine Dan

closely and regularly. Giving the mother messages and warnings as well as five months of

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Good Clinical Practice Dan Weiss and GCP

Fuad Almaweri

deteriorating without any progress or benefits raises many question under what reasons Dr. Olson

built his decision to extend Dan enrollment for six more months.

The delegate who was responsible for consenting the patient was also the patient social worker.

CRO Quintiles put a lot of pressure on the site to enroll more subjects. This study was designed

so that patients had to complete the trial for the full payment to be received by the institution.

For this reason, dropping the patient because the study drug was ineffective, or adding

additional medications, was not an option and would have resulted in significant decrease in the

financial fund.

Negligence:

The investigator delegated the consent process, patients follow-up and dispensing investigational

medications to unqualified person without proper training or previous experience. For example:

She acknowledged that Dan lost about 15 pounds in short time, which is a point of concern, but

she did not inform the investigator.

Inadequate follow up to all the mother Mary Weiss concerns and warnings that Dan may commit

suicide.

The IRB failed to ensure adequate protection to vulnerable subject, by approving a risky protocol.

As well as failed to review Dans death thoroughly.

The protocol prohibited the investigator from monitoring drug concentration in patients blood,

which would indicate the real compliance. It prevented subjects from being pulled out their

assigned drug or to switch them to another drug if the assigned drug was not working as in Dans

case. Also restricted the Number of additional drugs subjects could Be given to manage side

effects and symptoms such as depression, anxiety, Or agitation.

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