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RRP ISA Survey Results
    Professionals & Researchers

    (Important Disclaimer)


    Professionals & Researchers

    Informed Consent & Safety Issues Pertaining to MMR and Other Experimental Treatment Procedures

    Bettie M. Steinberg, Ph.D.

    I am writing in response to several postings on the Message Board about the use/possible problems of the MMR vaccine to treat RRP.  However, my comments apply to all experimental studies for RRP, not just MMR.  

    All types of treatments have possible side effects.  With FDA-approved treatments for disease, these side effects are generally known and the risks have been determined to be less significant than the benefits of treatment.  With experimental treatments, this is not the case.  Either the risks are not known at all (e.g. in the case of a new treatment or drug) or the risks have not been weighed against the benefits of the treatment (e.g. with a new use for a previously used drug), because the benefits have not been well tested.  Any new or experimental treatment therefore needs to be carefully studied to determine what is called the risk/benefit ratio - the balance between possible side effects and possible improvement in disease.  The treatment also needs to be carefully studied so that we can, in the future, develop even better and safer treatments for RRP based on the knowledge we gain.
     
    When such studies are done at large hospitals/medical schools, they must first be approved by a committee called the Institutional Review Board (IRB).  This is a committee composed of doctors and nurses from the institution and also people outside the medical profession from the local community.  The purpose of the IRB is to protect patients against unnecessary risk and to make sure that they know and understand all the risks involved in participating in the study.  To do this, the physician will submit to the IRB a detailed description of the study, including all known information about possible side effects and the scientific reasons why they think the treatment will benefit patients, and a copy of the consent form that patients will sign.  This consent form provides the patients with all the information they need to be able to decide whether to participate, in language they understand - not medical jargon.  When the IRB is satisfied that the study is reasonable, that it does not expose the patients to unnecessary risk, and that the patients will truly understand the risks involved and the other options they have instead of the proposed study (this is what we mean by informed consent), the IRB will approve the study.  Only then can the treatment be used on patients. The IRB then monitors the study for as long as it goes on, collecting data on any side effects and improvements, as well as all appropriate laboratory studies that might provide information on the basis for any possible side effects, to make sure that the original information is correct and that the patients are protected.  If any new unexpected problems arise, they can stop the study. 
     
    Ideally, all non-standard treatments would have IRB approval.  At the least, all patients or their parents who receive non-standard treatments, whether in surgery or in a doctor's office should sign a consent form that provides all necessary information so that the patient or parent can make a truly informed decision whether to use the treatment.  If such information is not provided to the patient or his parents, I would be very concerned about their participation.
     
    In the case of MMR treatment, for example, the consent form would describe all known side effects of the vaccine (fever, rash, possible arthritis symptoms with painful and swollen joints, swollen lymph nodes, possible excessive bleeding and possible allergic reaction).  The side effects would be listed in order from the most likely to the least likely but including even rare side effects so that the patient would know all the risks.  It would also state that these side effects are the known side effects of a single dose used for standard vaccination, and that the side effects of multiple doses injected at one time might be different or might be more severe.  With a treatment like MMR, where the purpose is to stimulate the immune system (although we don't know how it works and don't know if this is really what is happening), it would be appropriate to do some standard blood tests for a stimulated immune system and tests to determine whether there is evidence of an autoimmune disorder starting.  Regular monitoring would not necessarily prevent triggering of arthritis symptoms after the first treatment, for example, but might indicate a response in that patient that would indicate an increased risk of triggering such symptoms with repeated treatment.   
     
    I am not advocating any particular treatment for RRP in this discussion.  There are many options currently available in addition to surgery - interferon, indole-3-carbinol/DIM, cidofovir, and MMR, in addition to our celecoxib study.  All will have some possible side effects, and all may benefit at least some patients. The important thing is for patients to make an informed decision about which treatment they want to try, based on knowing what the risks are and having accurate and complete information on what is known about responses or the reason why such responses might be expected. 
     
    In the long run, we all want the same thing - effective treatments for RRP and someday hopefully even prevention.  It is just important that patients have all the information necessary to decide what they are going to use for treatment until that time comes. 
     
    Bettie M. Steinberg, Ph.D.
    Associate Director and Chief Scientific Officer
    Institute for Medical Research at North Shore - LIJ
    270-05 76th Avenue
    New Hyde Park, NY 11040
    phone: 718-470-7553
    fax: 718-347-2320