Experimental Treatments and Trials: Is Hope the Only Option?
Recently, some parents I know were discussing experimental treatment for food allergy, as one family was getting ready to enter a clinical trial. “Hope is the only option!” they all agreed.
But is hope really the ONLY option? Can scientific rigor, patience and even healthy skepticism be options, too? Could hope actually be, in some cases, an impediment to making an informed decision, or to being prepared for the hard work of a clinical trial?
If you are considering a food allergy clinical trial for your child, here are some questions you may want to consider:
1. Have you accepted your child’s allergies as they are today?
Have you been modeling for your child how to integrate their food allergies into their life — or has the family harmony been in a state of disruption while you wait for a cure? If the treatment doesn’t work and you return home with the same allergies and the same child, will you feel like anything (or anyone) has failed other than the trial itself? Does your child understand this as well?
2. Do you and your child understand the physical rigors of undergoing experimental treatments?
Most Oral Immunotherapy (OIT) starts off with doctors administering just enough of an allergen to determine the child’s threshold… which means bringing them to the brink of anaphylaxis and treating them medically to prevent severe shock. Has this been explained to your child, and are they prepared for the fact that anaphylaxis may also occur during the trial? For Chinese herbs (TCM), there is a lot of work involved (taking multiple herbs, daily soaks, frequent cream applications). Is everybody in your family, including your child, prepared for what’s to come?
3. Is there informed consent?
Has your child given informed consent: understanding the risks and knowing they have the “out” to leave the study without guilt if they so choose? Are they old enough to understand and give consent? Are you and your child comfortable with the parameters of the study?
4. Has your allergist — using numbers and facts — told you the odds of success or failure?
If it’s a clinical trial or experimental treatment, it means they are still testing their ideas and more research needs to be done to determine if it will (or won’t) become a useful treatment that is accepted by the larger medical community. Has your allergist explained what researchers know, and what questions they are still trying to answer?
5. What will happen to you if the treatment doesn’t work?
If you travel home from your final appointment with the news that it hasn’t worked, what type of conversation will happen in your car or transit? Will you take a balanced view of the results, or feel an embittered sense of lost hope? Are you ready for your child’s tough questions? Ready to go back to the way things were?
6. How hopeful is your child?
What if you are a hopeful parent with a pragmatic child, or a pragmatic parent with a hopeful child? How will you reconcile these differences?
7. What about anxiety?
Fears about reactions or other health concerns are natural, and for some, these are a clear barrier to participating in a clinical trial. You know your child, and yourself, and what those limits are. Your GP and other care providers can also help to get a sense of whether it is psychologically appropriate to go forward with a trial. And remember that, if your child undertakes a study, fears about getting an unwanted result (being disqualified, etc.) can also come into play. Pressure to succeed could lead your child to hide their feelings (and their reactions). Your allergist should be modeling a low-pressure approach, which hopefully everyone will adopt.
8. Is the experimental therapy scientifically valid?
Does it seem worth the risk to you? There are certain therapies that have no medical value and are dangerous (NAET and chelation, for example). But keep in mind that for any experimental treatment, there is risk and you are entitled to feel and express all your questions, even doubts. As a physician, your allergist should give you clear answers (and cite peer-reviewed studies). Good scientists trust facts over magical thinking. No one should be offended by your questions or see them as negative.
Nor should you; you can be a pragmatist and still be optimistic. In fact, you can even be pessimistic and it actually won’t impact the scientific outcomes of the trial… at all! Whether you are thoughtful, skeptical or otherwise, there are many paths to take in considering to enter a clinical trial. Hope most certainly is not the only option, and hope — on it own — is clearly not even the best option.
NOTE: I am not a medical professional. The perspective above is very much a layman (or laymom’s) perspective.
Republished with permission from Anne King’s blog May Contain.1 of 3