Bioethics Discussion Blog: Patients Volunteering for Research and the “Therapeutic Misconception”

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Sunday, April 20, 2008

Patients Volunteering for Research and the “Therapeutic Misconception”

A patient volunteers to participate in a drug research project which is related to the patient’s own illness. The question is: why would the patient want to participate? An obvious answer might be that the patient is motivated about the possibility that the new drug will benefit recovery or management of the illness better than the drugs which the patient has been prescribed. The patient may believe that he or she will, in the study, will have access to the new drug. This thinking and believing really represents a misconception. It is based on the patient’s conception, which may be fostered by inadequate or misleading information about the study, that sufficient benefit to the patient’s illness will be the result of participation in a clinical trial that will trump any of the risks of the study. This is the “therapeutic misconception”, a term invented by Roth, Appelbaum and Lidz some 25 years ago, regarding patient involvement in clinical research.

What is the misconception? Well, first might be the patient considers him/herself as a patient in the study. Many studies are designed not to treat the volunteer with the appropriate illness as a patient but to consider the volunteer as a experimental subject. Yes, in the United States there are overseeing governmental mechanisms in clinical research attempting to protect the human volunteers as human subjects but not necessarily as patients. Being attended to as a patient demands that the professional keep only the best interests of that patient in the decision making. But, in clinical research, the goal is to attend to the best interests of the research study. For example, toxic effects of drugs on the volunteers are generally monitored and if the risk to the volunteers, through statistical monitoring, becomes greater than initially anticipated, the study is stopped. Well, one would agree with that kind of interest in the study subject. But sometimes, if the beneficial results of the drug study are strongly positive, and this is also monitored, then the study also may be stopped to conserve the costs but perhaps only to the detriment of the patient whose illness was improving with the drug under study. There, unlike in usual medical practice, benefit for the patient is ignored. A complicating issue in this conflict of benefits is when the patient’s physician is also a member of the research team (a topic which I covered on this blog in February 2005 as “Wearing Two Hats: Clinician and Researcher”). How can the physician resolve the conflicting responsibilities?

Another misconception is that the patient will receive a drug in the study which could be to the patient’s benefit. The basis of a true clinical research random controlled study is not to study the known but to study the unknown and undetermined. The usual first approach to study the unknown is to discover if a drug has benefit for a patient as compared with no drug (a placebo pill). If there are already drugs available to treat the illness, then another unknown would be to determine if the new drug’s known benefit is better than the other drugs benefit. This can be tested by a study comparing the beneficial effects of the new drug against the established drug. The studies are performed by, in the first case providing the new drug to one group of randomly selected patients and providing the second group of randomly selected patients the placebo. The second group will not be treated with an active medication. If it turns out that the new drug is ineffective, the first group will get no benefit. The risks include the possible absence of an effective drug in the first group and both groups may not be getting benefit from an established drug for their illness during the study.

In the second case, one randomly selected group will get the new drug and the second randomly selected group will get the established drug. The first group may not be benefitted by the new drug. The second group may not have the benefit of the new drug, if that drug is found better than the established drug. Again, the risks for the first group would be not getting benefit from an established drug if the new drug is less beneficial. For the second group, they would be missing the opportunity, if the new drug is more effective, to take the new drug.

So what does this all mean? It means that volunteers must realize that a clinical study is not a treatment, it is an experiment. The volunteers should be aware that they are not patients, they are experimental subjects. The volunteers should know that they will be randomly selected, will not know to which group they have been selected and they may not be given a drug that is effective treatment for their illness or may be given one that is less or no greater benefit than established drugs for their illness. They should know that during the study, the pill they are taking may be inert or less effective than the drug they had been taking previously. Finally, there is no guarantee for any participant that an effective drug found by the study will be accessible or available for treatment of the patient after the study is finished.

What this all this also means is that all volunteer patients should personally make certain they obtain and understand, as part of the informed consent,the full nature of the study they are considering to enter, the role of their own physician in the study, the risks that they are undertaking and the hoped for later benefits and understand that their participation really should represent their own altruism, to sacrifice themselves for other’s (and hopefully their own) later benefit. This “conceptual clarity” on the part of the patient at the outset should remove the possibility of the therapeutic misconception. ..Maurice.

11 Comments:

At Monday, April 21, 2008 7:13:00 AM, Anonymous bob koepp said...

Maurice - I think the largest contributor to this problem is clinical researchers themselves, since very few of whom have spent more than a moment reflecting on their "two hats." Typically, when a physician "invites" a patient to participate in a clinical trial, attention is _not_ directed to the difference between the goals of research and the goals of therapy. Patients, of course, _assume_ that if their physician suggests (I think it often amounts to a _recommendation_) participating in a clinical trial, it's because the doc thinks this is the best _clinical_ course. If only they knew...

 
At Monday, April 21, 2008 8:26:00 AM, Anonymous Anonymous said...

"So what does this all mean? It means that volunteers must realize that a clinical study is not a treatment, it is an experiment"

I was looking for a line like above while reading the post. I think many volunteer patients know this fact but they WANT TO BELIEVE that there is a chance to cure their ailments even knowing that they could be taking the placebo. In their minds, especially in the case of a terminal illness the one in a thousand chance that it may work is better than nothing.


TS

 
At Monday, April 21, 2008 9:23:00 AM, Anonymous AG said...

I would also like to point out that a clinical trial is an "experiment" only if it's a good clinical trial. Most of the clinical trials I've seen are not designed to answer an important clinical question, but will be used for marketing purposes. To me, this is one of the greatest deceptions of the people/subjects participating in the trial. They often want to do something that will either help themselves or others, but are really helping a marketing program and a pharma company's bottom line.

 
At Monday, April 21, 2008 9:53:00 AM, Blogger Maurice Bernstein, M.D. said...

I would feel better that the physicians would be making their "recommendations" more objectively if they too participated for altruistic reasons and were not payed a stipend by the pharmaceutical company for each patient which they enrolled into the study.

Speaking of the altruism of the patient volunteers, there is even a suggestion that their altruistic participation in the study may be for no purpose. What about the pharmaceutical companies who fail to publish the study if the results are not in their favor. By this decision, the companies not only waste an intellectual product but waste all the altruisic behavior expressed by their patient subjects. Do you think that he drug companies as part of their "informed consent" to the patients say "If during the trial the drug is clearly beneficial, we will terminate the trial prematurely so we can save money and start promoting the product. If during the trial or at the end, the drug appears to be of no benefit to patients or of no benefit for the company, we will not publish the study"? Yes, if the drug company actually said that, I would think that any consent on the part of the patient would truely be informed! ..Maurice.

 
At Monday, April 21, 2008 2:55:00 PM, Blogger Joel Sherman said...

Well it's a good question. Should anyone ever participate in a clinical trial? I suppose as one who starts off with a profound distrust of big pharma, I would want to see the study prospectus before I agree. But most people couldn't understand it, and I wouldn't necessarily either.
If the study is university backed, many(?) insist that negative results be published. Is there some pertinent federal law? I thought there was.
If the study is coming out of doctor's office, you might want to know what the arrangement is and how much they are getting paid.
Of course some studies use paid volunteers, and there the questions are different.

 
At Monday, April 21, 2008 3:55:00 PM, Blogger Maurice Bernstein, M.D. said...

In the April 16, 2008 issue of the Journal of the American Medical Association (JAMA), there are 2 research articles and an editorial about the the unethical and unscientific behavior of pharmaceutical giant Merck in the documentation of their research projects with their anti-inflammatory drug Vioxx. The authors of the first article "Guest Authorship and Ghostwriting in Publications Related to Rofecoxib [Vioxx]" conclude "The case study review of industry documents demonstrates that clinical trial manuscripts [research results articles]related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts [general articles discussing Vioxx tests and value] were often prepared by unacknowledged authors and subsequently attriuted authorship to academically affiliated investigators who often did not disclose industry financial support." The other article described how Merck, by manipulating the method of statistical analysis underplayed the "Reporting Mortality Findings in Trials of Rofecoxib [Vioxx] for Alzheimer Disease or Cognitive Impairment". Again, what this means is a demonstation of drug company interest not for the benefit and safety of patients but for the financial benefit of the company, its employees, its stockholders. It shows the same lack of concern about the development of valid, unbiased scientific documentation by some academicly affiliated investigators and physicians but only attention to their own financial benefit. And finally, as the JAMA editorial points out, the science and medical journals themselves have been lax by allowing the publication of articles which have not been adequately screened for unethical and unscientific behavior on behalf of those submitting the article.

This represents more evidence that one can consider any altruism by the patient volunteering to participate in a clinical study a wasted societal goodness and adds another element ["the study I am joining will be published in a scientific and unbiased manner"] to the potpurri of the patient's "therapeutic misconception". What a shame. ..Maurice.

 
At Wednesday, April 23, 2008 1:01:00 PM, Anonymous lady patient said...

Thank you for explaining the "politics" of clinical trials. As a cancer patient currently in remission, I wondered why my oncologist had not recommended any of the maintenance trials that I've been reading about. Perhaps he is cautious due to the many considerations you have listed.

 
At Monday, April 28, 2008 6:55:00 PM, Anonymous Anonymous said...

sbp: A woman with OVCA said, knowing her chances of success with the trial were neglible, that she was participating in hopes that it might help to provide information helpful to women "further down the line."

 
At Monday, April 28, 2008 7:04:00 PM, Blogger Maurice Bernstein, M.D. said...

To take personal risks with an experiment for some potential but unknown benefit for others, I think represents true altruism. ..Maurice.

 
At Saturday, May 03, 2008 3:37:00 PM, Anonymous Anonymous said...

To take personal risks is one thing, but when the personal risks are understated is quite another. The clinical trial last year involving gene therapy for patients with moderate arthritis is an example of a trial illustrating many questionable ethical issues. Starting from the consent form… to the design of the trial …to the death of a patient, several ethical issues surfaced one of which was therapeutic misconception. How can the average public be well-informed enough to understand the serious risks involved with gene therapy especially when one does not have a life threatening condition? Is this taking risks for the benefit of others or an act of ignorance? WDOS

http://www4.od.nih.gov/oba/RAC/minutes/RAC_Minutes_09-07.pdf;
http://www4.od.nih.gov/oba/RAC/minutes/RAC_minutes_12-07.pdf

 
At Friday, November 23, 2012 4:14:00 PM, Blogger Maurice Bernstein, M.D. said...

RBS wrote me the following e-mail today and gave me permission to publish it here. ..Maurice.


Dr. Bernstein,
I have been an avid reader of your blogs for several years and have even been included in one of your posts. For reasons of fear of retaliation, I am writing to you under a pseudonym. I would like to address the issue of therapeutic misconception. This editorial recently appeared in our local paper. I find it confusing. Are clinical trials typically considered "treatments?" I find this language somewhat deceptive. I do not see the word "research" mentioned anywhere. I've modified to mask the name of the institution. They have also run many ads claiming the same.
Thanks for any thoughts.


Clinical trials a source of hope

ThisHospital is giving cancer patients a chance to participate in clinical trials. For some, radiation, chemotherapy or surgery may still be the solution. But for others, clinical trials can offer new treatment options that — more than anything else — provide hope during the battle. “Many people think that clinical trials are only offered as a last resort effort and are typically only available in an urban setting, but this really isn’t the case,” said This Person, oncology clinical research manager for ThisHospital. “Clinical trials are treatments that have already passed rigorous testing, and at ThisHospital we offer clinical trials for several different types of cancer.” ThisHospital has 114 open trials for adults and 14 for children. They are for, but not limited to, leukemia, lymphoma, melanoma, sarcoma and breast, bladder, prostate, pancreatic, colon, renal and gynecological cancers. This year alone, 84 patients have been enrolled in the trials, including nearly 60 at ThisHospital in ThisCity and 10 each at ThisHospital Site and ThisHospital-Site. “It is important to note that clinical trials are not for everyone, but for those who qualify, cancer clinical trials provide access to cutting-edge therapies that may not only help their cancer but lead to new standard treatments in the future,” This Person said. “It is important for people to understand that all standard therapies used today were once clinical trials. Clinical trials are the key to fighting cancer and finding a cure.” If you would like to see what trials are available at ThisHospital locations, go to https://webapps. ThisHospital. org/findastudy/studies/ct.cfm. To find out if a clinical trial is available



 

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