Showing posts with label informed consent. Show all posts
Showing posts with label informed consent. Show all posts

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:  http://www.fda.gov/ICECI/EnforcementActions/ucm321308.htm

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.

Tuesday, May 20, 2014

'Immortal' Stem Cells and Informed Consent in California

The California stem cell agency is looking for some help in connection with a $32 million stem cell banking program to be sure that people who donate tissue understand that their cells will be transformed and made “immortal.”

The agency has issued a $150,000 request for proposals (RFP) for a 12-month study dealing with informed consent matters in the banking effort. The agency's RFP said it is “a unique program because it involves the creation of 9,000 iPS cell lines, from 3,000 individuals” that could increase to 5,000.

The RFP requests a report that will provide “in-depth analysis of donors' current understanding with respect to the informed consent process” and “recommendations for education materials that may improve program performance over time.”

Issues dealing with informed consent and research were highlighted a few years ago in a book, "The Immortal Life of Henrietta Lacks," that was on the New York Times hardcover bestseller list for more than 40 weeks. 

The California stem cell agency's RFP said,
“Unique aspects of the tissue collection for disease modeling awards that is critical for donors to understand include that researchers intend to:
“• Test donors blood and skin samples for infectious disease
“• Transform donor cells and make them into immortal iPSC lines
“• Record the genetic sequence of donor their cells
“• Distribute donor cells and associated medical and genetic information widely
“• Use cells and associated information to develop commercial medical products with no financial compensation to donors.
“In addition, minors and/or individuals with cognitive impairments will be recruited for this research and consent may be obtained from their legal guardian."

The proposed California study is linked to a $4 million segment of its $32 million stem cell banking effort approved in March of 2013. Former CIRM President Alan Trounson said at the time,
“This initiative will provide scientists with access to multiple cell lines that should have much of the genetic variations that represent the variety within any human disease such as Alzheimer’s, heart disease, lung fibrosis and autism.”

The deadline for applications is June 1. Here is a link to a 2010 CIRM report on issues involved in the stem cell banking program, which was only a proposal at the time.

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