Wednesday, July 23, 2014

Cloaking Informed Consent in Clinical Trials: A California Stem Cell Case

Patients come first. That’s the rhetoric from biotech companies and agencies like the FDA, which has oversight responsibilities for clinical trials.

But when it comes down to specifics, the doors may close and little revealed publicly.

The case in point involves StemCells, Inc., which was charged last week in a lawsuit with endangering patients involved in its clinical trials. The suit was filed by an unhappy manager who was fired by the Newark, Ca., firm. StemCells, Inc., said the charges lack merit.

But the firm is mum when it comes to the question of whether it has informed its patients about the allegations and its response. Those are the folks whose brains are being injected with what is alleged to be a product that is being manufactured improperly. They are supposed to give informed consent to the treatment and obviously need to know when serious questions are raised about their therapy.

Queried by the California Stem Cell Report about whether the patients in its clinical trials had been informed of the allegations, Ken Stratton, general counsel for StemCells, Inc., said,
“StemCells, Inc. has no further comment on the ongoing litigation or Mr. Williams’ allegations.” 
The FDA and the attorney for the fired manager responded in much the same fashion. Asked whether his client, Rob Williams, or he has notified the FDA about the alleged problems, attorney Daniel Velton said,
“We can't comment on pending cases.”
The FDA said,
“As a matter of policy FDA cannot comment on whether or not we are investigating or have plans to investigate any allegations.”
Questioned further about the federal rules for giving patients the information they need to provide informed consent, Paul Richards, a spokesman for the FDA said,
“Participation in any clinical trial is associated with some level of risk as the safety of investigational products has not been fully assessed. FDA’s primary responsibility is to determine whether the theoretical risks of the proposed study are reasonable and acceptable in order for the study to proceed “It is the responsibility of the study sponsor to conduct an investigation properly, to ensure proper monitoring of the investigation and to ensure that the investigation is conducted in accordance with the general investigational plan and protocols contained in the Investigational New Drug (IND) application.  The sponsor also ensures that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the product being studied.
 “Additionally, the individual who actually conducts the clinical investigation (i.e. the investigator) is responsible for ensuring that the trial is conducted according to the signed investigator statement, the investigational plan, and applicable regulations.  The investigator is also responsible for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. 
“In certain situations in which FDA alleges a clinical investigator has violated applicable regulations, FDA may initiate a clinical investigator disqualification proceeding.   FDA does maintain a publicly available database that provides information about disqualification actions.  Further background related to this topic is available at:

No doubt seems to exist that the patients should be informed about the allegations in the lawsuit. However, implementation of the requirement is considerably less than transparent. How does the public know whether patients have actually been informed?  How do the patients themselves know whether they have been adequately informed? Trust us is the operative and dubious response.

One must ask whether these tight-lipped non-responses are in the best interests of patients, biomedical research, the government or even the companies. Patients and the public deserve more than lip-service to the process of informed consent. The parties involved in the StemCells, Inc., litigation, as well as the government, can do better. 

What possible harm could result from simply saying, “Yes, the patients have been told of the lawsuit and the company’s response.” Such a response might help to inspire confidence among persons considering clinical trials and help recruit the patients needed to test possible new therapies.

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