A Memo to Pro-Lifers

Rather than take an adversarial position, those who are Pro-Life could adopt a more proactive approach, one that would advance their cause. Their understanding is that life begins at conception. Consequently, from their perspective any induced abortion constitutes murder and is illegal.

It follows that the first thing to do, is to do everything possible to prevent an unwanted pregnancy. Therefore, the first step in the Pro-Life agenda would be to promote the use of contraceptives. Make all forms of them available to those women who at this stage in their lives do not want to have a child.

One important way for Pro-Life advocates to accomplish that would be to set up and fund clinics to help women (and men) who do not want to have a child to get whatever form of contraceptive they prefer and to provide the funds necessary to accomplish that objective. In that way, Pro-Lifers would significantly help. Fewer women would be placed in a position where they would choose abortion as their best option.

Since that would not prevent all unwanted pregnancies, the next step would be to provide counseling at the clinics. It would inform pregnant woman about the costs and benefits of various procedures, including one which the clinic provides: to assist her through all stages of the pregnancy and the birth and to make arrangements for the infant’s adoption once it has been successful delivered. All costs, including the support of the woman during the pregnancy, would be covered by the Pro-Life group.

The group’s objective would have been met. Once the child is born it would be placed in a family that wanted it. An induced abortion would not have happened. This Pro-Life approach would have prevented that from happening. Moreover, the pregnant woman would be less likely to be placed in a position where she would consider an abortion as her best option and she would be fully supported during her pregnancy. Along with that she would know that the child would be well taken care of. It has the additional advantage that a family that wanted and would otherwise not have a child, has one. In addition, the Pro-Life advocates were instrumental in making that happen.

It will lead to fewer women who consider abortion as their best option. Moreover, whatever time, energy, resources and funds (TERF) that the anti-abortion advocates commit to the program will further their primary objective. Furthermore, they are less likely to cause resentment and hostility and to alienate others in the process.

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Should I Enter a Clinical Trial–Part Four

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

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

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

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?

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.

 

 

Variation in the Ability to Perform

thinkerFrom the time he was 10, my son, Paul, understood the relation between decision and action better than almost anyone I’ve ever known. Edie, my ex-wife, and I had just split up and I was living in what I thought would be a temporary apartment on the Parkway in Philadelphia. Paul came to visit for the first time and we were sitting on the grass in the shadow of Rodin’s The Thinker. Sad faced, Paul turned to me, “Dad, is it okay if we invite Ted?” He was Paul’s good friend who lived in Northeast Philly. “Sure,” I said. Paul lit up like a Christmas tree. A few minutes later the sad face was back again. “Okay, Paul, what is it now?” “Well, you said we could invite him!” Paul also had a fine understanding of process. He knew just what it took to get things done. Once he decided on something he went ahead and did it — until the job was complete. Again, no gap between decision and action.

Contrast that with his behavior at lunchtime. We settled in at a restaurant, menus in front of us. Sad face once again, he couldn’t decide what he wanted. My suggestions don’t help. Paul is hungry and unable to make a choice. Paul’s complex machine – we call it the body – which ordinarily has no problems making decisions and choices has broken down. Paul is very hungry. That’s the machine’s way of telling him it had been deprived of inputs and that because of that it couldn’t make decisions. It needed inputs – food – first. The human body is not always in the same, uniform steady-state condition, always ready to perform whatever tasks are required at the same level of efficiency. In order to function it requires a flow of the right inputs – water, food, rest, shelter, etc. – in the appropriate amounts over time. When it has them, it is capable of peak performance.

How often has this happened to you? You go to bed with a question on your mind. For example, you can’t remember a person’s name. In your mind’s eye you can see her face. You remember your last time together. But, for the life of you, you can’t recall her name. You fall asleep and wake up refreshed. And her name, Pat, pops up into your head. You think to yourself, “Why couldn’t I remember that last night?” If you think about it, the answer is simple. In order to be a well-functioning machine the body required one of the basic inputs — rest.