An Example of What Happened
We would like to provide a concrete example about the consequences of participating in a clinical trial. It is based on Amanda Bennett’s The Cost of Hope. She is a fine journalist and currently Executive Editor of Projects and Investigations at Bloomberg News. The book documents her husband, Terence Foley’s, seven year bout with kidney cancer. Initially, Foley was diagnosed with an atypical and aggressive form — collecting duct kidney cancer. It was spotted in December 2000 during the operation to remove his intestines to treat his ulcerative colitis. There were only 50 known cases of it worldwide at the time. This alone makes questionable whether his participation in the clinical trial contributes to our understanding of the potential benefits for future patients. In January 2001 when it was diagnosed, the prognosis was that he had a few months to live. [Bennett, p. 66] He died of it seven years later in December 2007. Continue reading “Should I Enter a Clinical Trial–Part Three” →
It is at best uncertain whether you or anyone else currently in your condition will benefit from your participation in a clinical trial. If the trial is successful — and as we have mentioned earlier not all of them are — and the drug or appliance is cleared for marketing, some of those who get a similar condition in the future may benefit from it. Your participation is your legacy to them. But the important question is, “Who benefits now?” That is particularly relevant since large amounts of time, effort and money go into clinical trials. Someone must believe the investment is worthwhile. Let’s take a look at each of the stakeholders.
Those conducting trials are stakeholders in it. They benefit from it. They include:
- The doctors and other practitioners involved.
- The organizations and institutions they are a part of and represent– the Medical Centers, Hospitals, Universities and PhysicianFirms.
- The pharmaceutical and medical equipment companies whose products are being tested and who sponsor the trial whose self-interest is definitely connected to the success of the project.
The principal investigators — a.k.a., the lead doctors — have their reputation on the line. The study is based on their hypothesis. If the clinical trial turns out favorably, they can say, “See I was right!“ Not only is that a boost to their ego, it enhances their reputation and all that goes along with it. If successful, they get to publish the results and present the findings at national meetings. Moreover, it enables them to test out their ideas, to get funds for their projects and it increases their income as well. Those personal benefits contribute to their wanting you to participate and, perhaps, inadvertently encourage you to do so. That is particularly true when the number of possible candidates for the clinical trial is limited, and the lack of participants threatens the validity of the results or even makes it impossible to conduct the trial. In fact, the possibility of being pressured to enroll has led to the requirement that in order to participate in a clinical trial you must sign a form indicating that you are giving your informed consent. Continue reading “Should I Enter a Clinical Trial–Part Two–The Beneficiaries” →
I — The Issues
With few exceptions, every prescription and over-the-counter (OTC) drug and medical device marketed in the U.S. has to be approved by the Food and Drug Administration (FDA) for efficacy and safety. That is where clinical trials come into play. They provide the information required for clearance. It is critically important to realize that for any drug or device in a clinical trial it is impossible to know beforehand what the outcomes of the intervention — both favorable and unfavorable — will be. No one — not even the best informed minds — know that. That is the reason for having a clinical trial. The trial is based on an hypothesis — a.k.a,, a guess. Sometimes it is correct, sometimes not. If the outcomes, or the range within which they fall were understood, there would be no reason for the trial.
Not all clinical trials are successful. Some drugs do not even make it through Phase I (which determines if the drug is safe and the dosage levels). Others are withdrawn before they complete Phase II (which tests for efficacy and safety). They can be withdrawn because they are ineffective, unsafe or have damaging side effects or considered to be non-profitable. Still others may not offer a significant improvement over current therapy represented by the control group. Only some of the ones that get through those hurdles are ultimately cleared for marketing by the FDA.
Continue reading “Should I Enter a Clinical Trial–Part One” →
We have all seen the ads on TV, heard them on the radio or read about them in a magazine. There are many clinical trials being conducted all the time devoted to the study of numerous conditions and potential treatments for them. It is likely that whatever condition you or a loved one may be dealing with, somewhere there is a clinical trial being conducted. Maybe you or someone you know has been asked to enter a clinical trial. Perhaps your doctor suggested it, and since nothing else seems to be working, you think, perhaps, it would be a good idea. You may be asking yourself “should I?” or “shouldn’t I?” In order to answer that question it is important to understand the nature of clinical trials and how participating in one will affect your life.
In this four part series we will address:
- What clinical trials are all about and how they work.
- Who are the beneficiaries.
- An example of what happened in one case.
- What to consider before deciding to enter one.
If you allow yourself or a loved one to “enter” a clinical trial it is important that you understand what you are doing, what is involved and what you can expect. Moreover, it is also important to recognize that the stakeholders have a significant vested interest in your participation. In this series of posts, it is our objective is to help you understand the likely consequences — the benefits and the costs — beforehand. Hopefully, we can help you make the decision that will be best for you. Please post your stories, insights and experiences. We always enjoy hearing from our readers.
One of the things that has made me feel isolated is my hearing loss. I don’t hear as well as I used to. High-end frequencies create the biggest problem. It is harder to hear what girls and women say, especially those who mumble or don’t speak clearly. It is challenging to understand dialects like those in British movies and TV programs. Figuring out what is being said is difficult and tiring enough but made even worse when someone has their back to me or we are in a noisy restaurant or at a stage performance. It can be a real chore.
Once a week my friends, Erin and Grace have a “Tea” salon. They invite friends for an evening get-together. They are in their 30s and they invite me. Wow! Sometimes there are just a few of us, sometimes many more. When the group is large and when there are side conversations, keeping up with what’s being said is hard. Especially when someone slides a side comment or joke into the conversation. The discussion frequently centers around music. Importantly, there are significant differences in our musical background. When I grew up in the late 30’s and early 40’s we had big bands, jazz, folk and North Carolina mountain music — the Dorsey brothers, Louis Armstrong, Cab Callaway, Gene Krupa, Frank Sinatra, Woody Guthrie, Pete Seeger, Lena Horn, etc. I saw Sintatra on stage at the Paramount Theater in Manhattan in the early 40s and Krupa’s band played at a dance at UNC- Chapel Hill later in the decade. It was the only time I went to a formal; I had to borrow a tux. I still hear sound of Krupa’s masterful drumming. Continue reading “Speak up, young friends!” →
My Mom, when she was 80, said to me, “Bernie, I wish I was 20 and knew then what I know now.” My response was, “Mom, That’s a contradiction in terms.” Perhaps by sharing my experiences and what I have learned from the time I was 20 until now can help others. Just to prove I’m keeping up with the technology, from time to time I post my experiences on this blog. Trust me, when I was growing up we didn’t have blogs! In the following series of posts on aging, I’ll tell you about some of the issues I’ve faced and how I’ve dealt with them. My hope is that this series will help you, no matter what your age, to understand some of the challenges older folks, like me, have.
Aging is isolating. It’s harder to get around. Friends die off or disappear. Your energy level ain’t what it used to be. You can’t do what you used to. Much of the new technology leaves you behind. Even though I use a computer and even have a blog, I never learned to text or twitter. I-Phones with their Apps are too difficult to deal with, even if I could afford one on my limited budget. People don’t talk to one another now, not the way we used to. Instead of picking up the phone they e-mail or text, and I don’t use a cell phone except for emergencies. Moreover, younger people have their own lives and appropriately, their own agenda. Continue reading “Aging” →