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    Secret Stem Cell Trial held in City


    Wise Young, Ph.D., M.D.
    W. M. Keck Center for Collaborative Neuroscience
    Rutgers University, Piscataway, New Jersey 08854-8082
    Posted 22 August 2005, last updated 22 August 2005

    I apologize for the headline, even though it is an actual headline from a new story from Cape Times, South Africa (see below). This news story reports a “secret” clinical trial in Cape Town that involves transplantation of autologous muscles cells from the thigh to the heart. Why is the trial "secret"? Now that I have attracted your attention, I want to discuss the reasons for secrecy of clinical trials and problems of having secret clinical trials.
    Secret stem cell trial held in city

    By Staff Writer

    Local research on the regeneration of damaged heart muscles through the infusion of stem cells holds promise as a major international medical breakthrough, although speculating about its possible success at this stage may be premature, a researcher has warned.

    A number of South Africans are said to be the first guinea pigs in the medical trial aimed at creating an alternative to the heart transplant. It has been conducted over the past eight months, although it has not yet been peer-reviewed, according to media reports.

    Rapport reported that all the patients with "new hearts", taking part in the "highly secretive" trial in Cape Town, showed marked improvement over the past few months. Stem cells were reportedly harvested from tissue in the adult patients' thigh muscles, grown in a laboratory and injected into their damaged heart muscles.

    But Dawie van Velden, a senior researcher at the medical faculty of Stellenbosch University, warns that the public could easily become over-optimistic about such medical news.

    "This modernistic approach to curing heart disease sounds wonderful and promising, but it is still in its beginning stages. One must be careful not to sensationalise research that hasn't been peer-reviewed yet," he said.

    Published on the web by Cape Times on August 22, 2005.
    © Cape Times 2005. All rights reserved.
    Most clinical trials are not secret. The federal government sponsored web site lists thousands of active and ongoing clinical trials in the United States. If you searched the site for "stem", you will find 295 clinical trials involving stem cells, i.e. 210 involving bone marrow stem cells, 64 peripheral blood, 13 umbilical cord blood stem cells, and the rest combinations of two or more of these sources. Clearly, many clinical trials of stem cells transplants, especially those involving bone marrow and umbilical cord blood, are not secret.

    Keeping clinical trials secret is difficult because permission must be applied for and granted at multiple levels. The Institutional Review Board (IRB) of the hospital must approve the trial. If the clinical trial involves any drug or will require FDA approval, the clinical trial must be registered and approved by the FDA, a process called Initial New Drug/Device (IND) application. Dozens or perhaps even hundreds of doctors and nurses are often involved in clinical trials. Hundreds or even thousands of patients may be involved. With so many people, the existence of a clinical trial may not remain secret for long.

    Many clinical trials ask their participants to sign confidentiality agreements and to agree not to discuss their treatment or results publicly for several reasons. Subjects talking about their responses with other subjects may break the blind (i.e. disclose some aspect of the treatment effect that may tell other subjects whether or not they have received the treatment, whether correctly or incorrectly). Anecdotal tales of unusual recovery may lead to unrealistic expectations and inappropriate influence on the informed consent process. Unwarranted rumors about a treatment’s efficacy may lead to people inappropriately signing up for clinical trials.

    Premature release clinical trial results, especially inaccurate or incomplete data, may have significant financial consequences. The financial future of companies and billions of dollars of stock value may be at stake, for example. The case of Martha Stewart is an example of potential abuse of insider information concerning clinical trials. There has been much concern recently that investment firms are paying large consulting fees and conducting interviews of clinicians participating in clinical trials (Source). Inadvertent or advertent passage of information about clinical trial results may have substantial financial consequences. For example, one document circulating on internet describes a financial analyst who signed himself up for a clinical trial just to find out about a clinical trial. Premature disclosure of an adverse event may cause stock prices of companies to tumble or anecdotal reports of dramatic recovery may lead to inordinate rises of stock value.

    Treatments may be proprietary and sponsors of clinical trials may not want treatment information or results publicized. Disclosure of treatment information or results may adversely affect the development of a treatment or provide competitors with damaging information. All clinical data is subject to interpretation and misinterpretation, particularly incomplete data that may not include all relevant subjects. For that reason, most sponsors of clinical trials require investigators to sign confidentiality agreements not to release the data without prior authorization by the company.

    Secret clinical trials present significant opportunities for misconduct. A sponsor may, for example, suppress negative or deleterious results of a clinical trial. This has been the target of numerous investigations whenever treatments are found to have deleterious effect. Billions of dollars may be at stake. Recent examples include the belated finding that antidepressants may increase the risk for suicide in children (Source), the discovery that the COX-2 inhibitor Vioxx increases the risk of myocardial infarcts and strokes (Source), and many others. Companies are legally liable if they have suppressed data.

    What about the right of patients to know? Is it moral or legal for a clinical trial sponsor to keep the identify or the details of treatment secret? Clearly, the FDA does not think that it is appropriate for scientists to withhold information about treatments in clinical trials. For example, in an article about medical fraud, the FDA lists four criteria by which people can tell that treatments are "phony":
    • secret formulas (Real scientists share what they know.)
    • amazing breakthroughs or miracle cures (Real breakthroughs don't happen very often. When they do, real scientists don't call them amazing or miracles.)
    • easy weight loss (For most people, the only way to lose weight is to eat less and exercise more.)
    • quick, painless, or guaranteed cures.
    Secret clinical trials may interfere with informed consent. If a person is participating in a clinical trial, the informed consent process requires that a participant has full access to information concerning the treatment, its beneficial or deleterious effect. It is inappropriate to discourage a potential participant to gather information about the treatment and obtain other expert opinions. Subjects in clinical trials must choose on the basis of information provided whether they want to participate or not. Although they can withdraw from the clinical trial at any time during the trial, the prohibition of disclosure is an abridgement of the informed consent process. The NIH-published web site defined informed consent as:
    INFORMED CONSENT: The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.
    A “secret” clinical trial prevents participation by people who may qualify in a clinical trial. Clinical trials exist for the purpose of determining the risk and benefit of a given therapy, so that scientists can develop better therapies and government agencies can protect public safety and regulate therapies. Clinical trials are not meant to provide people access to experimental and unproven therapies. Therefore, there is no absolute right to participate in clinical trials. On the other hand, participation in a clinical trial is a two-way street. In order to convince people to participate in clinical trials, clinical trial investigators must provide informed consent and there must be some benefit for participants. Although not illegal or unethical, keeping a clinical trial secret seems unfair.

    Secrecy also may prevent participants from knowing the clinical trial results. In theory and in practice, data generated in a clinical trial belong to the sponsor(s) of the trial and the investigator(s) but participants in a trial should have a right to know the results of the trial. Usually, the relationship between sponsors and investigators is defined in the research contract between the sponsor and investigators. Most universities will not allow its investigators to participate in clinical research that prohibit publication of the data because this infringes upon academic freedom. Sponsors usually demand that they be given a reasonable period of time (usually 3 months) to evaluate the data and submit patent applications or conduct other activities before publications. Also, both sponsors and investigators agree not to publish the data without each other’s permission. But, this arrangement leaves out participants. If the sponsor is the government, usually information concerning the clinical trial can be obtained through the Freedom of Information Act but this is not true if the sponsor is a private company or individual. The FDA requires prompt notification of any adverse event in a clinical trial regardless of sponsorship. Although the FDA generally keeps such information confidential, public pressure often can force public disclosure of such data. Also, data can of course be forcibly obtained through lawsuits.

    Knowledge of clinical trial results is important also because the treatment may not be approved by regulatory agency for months or years. If the treatment is beneficial to the patient, what is the obligation of the clinical trial sponsor to provide information concerning the trial results or access to the treatment? At the present time, this obligation is at the discretion of the company. A treatment that has not been approved by the FDA cannot legally be sold. At the same time, the government cannot force a company to provide free drug to people before the drug has been approved. Often, it may be months before the data is published in a peer-reviewed journal. Deprivation of clinical trial participants of information that may influence their health or perhaps even cause their death is clearly unethical and possibly illegal. While everybody knows about phase I trials (to establish safety and feasibility), phase II trials (to optimize treatment parameters and patient selection), and phase III trials (to establish benefit-to-risk ratios), few people know about phase IV trials that are called “extension studies or “expanded access” protocols. Patients who may not qualify for carefully controlled trials or who no longer have access to the treatment after the trial has ended are often enrolled in these studies or protocols. Ostensibly, the rationale for phase IV trials is to provide long-term safety data concerning the treatment but an important role of such trials is to provide access to investigational treatments. In addition, there is another category of investigational drug use, called “compassionate use” protocols that trial sponsors can apply for, to provide the treatments when there are no alternatives and the condition is life threatening or seriously debilitating.

    Since information is key to decisions to participation in a clinical trial and post-trial protocols, withholding treatment information and clinical trial results from participants requires extraordinary justification. The motivations for temporary withholding of information and avoidance of publicity during a trial are understandable and occasionally justifiable. However, clinical trials that are kept secret from the public after the trial is completed would be very difficult to justify. Secret trials are frowned upon by both doctors/scientists and government agencies. Extraordinary justification should be required to carry out “secret clinical trials”. In my opinion, secret trials should not be allowed because of the risks they pose and the lack of benefit to society.

    In summary, a news report of a “secret clinical trial” brought up some disturbing questions. Most clinical trials are not secret. Keeping trials secret is difficult because of the number of people involved. Many clinical trials nevertheless ask their participants to sign confidentiality agreements, partly because premature anecdotal disclosure of treatment or adverse effects may inappropriately influence other subjects, lead to unrealistic expectations, and interfere with the informed consent process. Premature release of clinical trial results, especially inaccurate or incomplete data also may have significant financial consequences. Sponsors of clinical trials may not want treatment information or results publicized. However, secret clinical trials present significant opportunities for misconduct and bring up many difficult issues. Confidentiality agreements unfortunately abridge the informed consent process by prohibiting disclosure and discussion of the experimental treatment and protocol with others. Although there is no absolute right of people to participate in clinical trials, secret trials prevent participation of people who may qualify for the trial. Secrecy also may prevent participants from knowing the clinical trial results. Knowledge of the clinical trial results is important because the treatment may not be approved by regulatory agencies for many months or years. Phase IV or expanded access trials allow access to treatments before approval. Since information is key to the decision to participate in Phase IV trials, timely disclosure of clinical trial results is important. Secret clinical trials must have extraordinary justification because they pose significant risks to participants and have little benefit for society.
    Last edited by Wise Young; 08-22-2005 at 12:28 PM.

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