Can a Dinner, Free Pizza, or Square Dancing Beat Ethics in Alzheimer?s Drug Trials?
Alzheimer’s disease is a killer, and it tortures the patients and their families, but finding a “cure” presents questionable drug trial ethical concerns.
Advances in healthcare and medicine are only possible through the use of clinical trials with volunteers who agree to participate, and it is this cohort that will determine whether or not a medication is acceptable to proceed to prescription for patients. In addition to the usual volunteers who are recruited from the pool of individuals selected, some are "professional" participants who watch for clinical trials and then volunteer for them.
Unfortunately, these individuals, who spend their weeks, months, or years in clinical studies, receive little attention in the professional literature. However, they are among the healthy volunteers who come forward and would not be denied entrance if they met the study's required entrance/exclusion criteria.
I've known sleep studies in which individuals had agreed to be secluded in a room for many weeks, where they had no contact with the outside world, no phone, no current newspapers, and even members of the staff who interacted with them, such as young men, shaved before they went into the volunteer's room. The shaving prevented the volunteers from guessing how long they had been there and estimating the time of day by that activity. And, yes, the researchers paid them a set fee for the entire study.
Usually, these pro individuals are sophisticated and understand the mechanics of these trials and also what is required in terms of medication "washout." Carefully prepare for each clinical trial in which they will want to volunteer.
How Are Clinical Trial Volunteers Recruited?
Previously, volunteers for clinical trials could expect to see notices in newspapers, on bulletin boards, have a request made by their healthcare provider, or some other referral means. The Internet has now released the search to vast numbers of people worldwide, and it is easy to find a clinical trial for most illnesses or disorders. Simply google "clinical research trials recruiting for…" and you will be referred to a website that contains a search for volunteers.
The US government, associations, private entities, or large pharmaceutical corporations may maintain these websites. All clinical trials that will be applied to human patients eagerly seek and rely on volunteers. Therefore, they have great value, and many different types of inducements may be used to attract them to a study.
Healthcare professionals are familiar with the history of inducements to prescribe specific medications. They have received invitations to exclusive dinners, vacation resorts, or even fishing trips. Depending on the value of the prescription, the inducement will vary accordingly. Several years ago, restrictions were placed on many expensive inducements such as computers, lavish trips, expensive gifts, or textbooks, handed out by detail persons aka sales representatives.
In retirement communities, especially where large cohorts of older adults live, research trials for dementia, Alzheimer's, or even Parkinson's and other illnesses are sought. They use well-established ways, such as dinners, game shows, participation in various activities, and other means, to induce people to volunteer. Now we need to consider another aspect of clinical trials that has been recently brought to a broader audience's attention: informed consent.
Who Is Chosen & How
When a clinical trial is being considered, an extensive document containing all aspects of the proposal must be submitted to an institutional research board (IRB) that will review it, make recommendations, ensure that it provides for informed consent, and either agree to it or require additional changes. This board protects volunteers and is extremely important in all clinical trials of pharmaceuticals or medical devices.
Part of the protocol will include the inclusion and exclusion criteria so that the final sample is not skewed in some way and will relate only to the disorder being researched. I was involved in national clinical trials of Alzheimer's disease medications, and two of our exclusion criteria were no history of alcohol, abuse or history of a family sudden cardiac death events. We had to exclude two women from one protocol. One family even offered a large sum if we would include their mother in our clinical trial. Of course, we could not make that exception.
Today, more and more clinical practice is relying on blood-based biomarkers (BBM) to bolster an AD diagnosis. Biomarkers for Alzheimer’s disease provide a more accessible and less expensive alternative to more conventional diagnostic methods, such as positron emission tomography and cerebrospinal fluid biomarkers. This is in line with the belief that amyloid is the basis for the development of Alzheimer's. However, this hypothesis is still being debated.
The Ethics of Research
Blood testing has been used for clinical protocols for Alzheimer's, and whether or not the volunteers should have been told the result is in question. Some contend that without this knowledge, anyone who would have required this in terms of informed consent was entitled to know because there could have been negative consequences.
Volunteers have suffered strokes, and there were deaths in those who had positive BBM’s after they received protocol medication. If stroke or death is a possibility, should volunteers be informed of that beforehand? This question is now being seriously considered, and protocols that identify persons at risk may need to be changed.
The relationship between Aß and AD is still not established to be causative. Although a blood test could be indicative of the presence of amyloid, researchers still question whether or not that proves Alzheimer's.
Research protocols are undoubtedly necessary for medical advances in disease and healthcare. Nevertheless, when a treatment carries the risk of physical harm, disability, or death, healthcare providers must exercise great care to ensure they do not violate the mandate of "first do no harm."
Additionally, as I have noted in my travels, any researcher who uses unethical practices must be called out. I once saw a patient who did not wish to sign on to a research protocol. As she left, the researcher said something startling: "You can leave this office and drop dead right now," he said.
The intimidation was blatant, but she left without signing up for the research protocol. Would being in the research have saved her from that fate? This is ludicrous in the extreme. Yes, desperation in medical settings often pushes people to behavior like this, but it is never warranted.
Desperation on the part of patients with severe illness that can mean death or serious impairment can also push patients to become involved in questionable protocols that have not been carefully monitored. Who should care for these volunteers? Everyone in healthcare bears this responsibility because each of us may hold a patient's life in our hands, and that is a trust that cannot be downplayed.
source http://www.expertclick.com/NewsRelease/Can-a-Dinner-Free-Pizza-or-Square-Dancing-Beat-Ethics-in-Alzheimers-Drug-Trials,2024307313.aspx
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