Should I Enter a Clinical Trial–Part Four

~ Bernie K. ~ 1 Comment

What to Consider Before Deciding

choiceIntervention is frequently based on the medical and public perception and assumption that doing something is better than doing nothing. That is not always the case. There are times when the net benefits of all interventions are negative — that is, anything you do will make you worse off.  Rather than starting with the underlying philosophy, “You/We should be able to do something that will fix it” begin by asking what are the likely benefits and costs of each of the alternatives. Then chose the one where the net benefits — the benefits minus the costs — are likely to be the greatest. Take no action when that provides the best results.

When the patient/consumer is not paying for the service, he/she is placed in the position of not having to consider what they are giving up when having the procedure. When that happens they are more likely to elect to have more services than they would if they had to pay for them. Historically, that goes under the name “Moral hazard”. Moreover, the prescribing practitioner and the PhysicianFirm almost always benefit from the additional revenue they receive from providing those services. Often it is someone else, like an insurance company or the government, who ends up paying the bill. Continue reading “Should I Enter a Clinical Trial–Part Four” →

Should I Enter a Clinical Trial–Part Three

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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” →

Should I Enter a Clinical Trial–Part Two–The Beneficiaries

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The Beneficiaries

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.

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” →

Should I Enter a Clinical Trial–Part One

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I — The Issues

Clinical_trials_LGWith 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” →

Should I Enter a Clinical Trial?

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pillsWe 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.

 

 

Speak up, young friends!

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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 reganand 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!” →

Aging

~ Bernie K. ~ 2 Comments

george-booth-i-would-embrace-the-aging-process-if-i-could-lift-my-arms-new-yorker-cartoonMy 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” →

The House I Grew up in

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bernie's houseAbout a month ago Grace Camblos, a biographer, photographer, and author, invited me to participate in a four week memoir writing class.  One of the “prompts” she gave to us was to write about, “The house I grew up in.”

I remember it well. The address was 144-15 33rd Ave., Flushing, Long Island, NY. We moved there in about 1938. It was a two-story house with a finished attic and basement and was the third of three houses on the block. They were the first of many, built by Abraham Levitt, who went on to develop Levittown on Long Island and in Pennsylvania.

I was 14 in September of 1942 and I just got back from eight weeks at Camp Man, the Queens County summer Boy Scout camp, at Ten Mile River in upstate New York. It was a Monday morning and the High Holidays had just begun.  My grandmother’s room was just next to mine at the head of the stairs. I got dressed and was heading off to school — to Fieldston. As I passed my Mema’s room, her full-time nurse came out and said, “I can’t revive her.” We went into her room and turned her over so she was face down with her head to the side. I climbed on top of her and rhythmically pressed down on her rib cage administering artificial respiration 1940’s style, that I learned how to do as a Boy Scout.There was no resistance, no push back. Her body did not respond to the pressure. I could not revive her. Reality struck. I felt the difference between life and death. I felt it in my hands.

Continue reading “The House I Grew up in” →

The Cost of War

~ Bernie K. ~ 2 Comments

We all know that war and any other aggressive action, by its very intent, causes damages and destruction. It is likely to cause death, damage, destruction, injury and disability to the “enemy” — and to ourselves and our own forces as well. Moreover, each action always involves time, energy, resources and funds — all of which could have been used for something else. It is essential to understand and plan for the resources required before taking any action.

Moreover, any action will almost certainly provoke a “retaliatory response” requiring additional resources to react to it. There is an almost instinctive, virtually automatic, retaliatory reaction to any initial aggressive act — meet aggression with aggression. Frequently it leads to an escalation of the conflict. Robert McNamara was Secretary of Defense during the Vietnam War. His important post-Vietnam advice was — understand your enemy before engaging in hostilities and taking any action. Add to that the likely collateral damage and the potential for unforeseen and unintended consequences and the additional cost of providing compensation and restitution for any damages and injury caused, certainly to one’s own forces, and perhaps to others as well. All those factors contribute to “The Cost of War.” Be mindful of them. Continue reading “The Cost of War” →

Thinking About How You Spend Your Time

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Enshi-girl-with-teaTime is a limited resource. There are just 24 hours in a day. No more, no less. All mammals must consume the basic survival inputs — clean air, fresh water and food, resting and using clothing and shelter. Time must be spent gathering, preparing or producing the food and other inputs, in making them ready for consumption, and in cleaning up afterward. Whatever time is not spent on those activities is available for other things.

If you are not directly involved in making any of those inputs, someone else must do that. In order to compensate them for the time, effort and other resources they spent in the production of inputs and making them ready for your consumption, you must use some of your left over time to create an income — either as physical outputs or their monetary equivalent — to pay for the goods and services they provide. That enables you to compensate them. Otherwise, you are expecting or getting a gift from them.

You’ve heard of discretionary spending. It is buying things after you have taken care of the necessities. The same thing goes for time. Once you’ve utilized your time to take care of providing the basic inputs, you have the opportunity to allocate the balance of it to those other things you want to do most. But the available time is limited. Every hour you spend on anything, you are giving up the possibility of using it for something else. Typically you have a number of alternative ways to spend the next hour. Some are more important than others. Clearly, spending time on the basic necessities comes first. After that, then what? Continue reading “Thinking About How You Spend Your Time” →