Medical Clinical Trials- Would you?

[Chuck Wintle]

Last week I had a family member in the hospital with a serious issue. While in the emergency room, one of the doctors made a call and said "We might have a candidate for you", then hung up the phone. They later explained there was a clinical trial going on and it might be something to consider doing.

About 30 minutes later, this young lady comes into the emergency room and says she's the one with the clinical trial. She explains it's a 7 year study and they are 1 year into the study. You will never know your own results, it's all part of the long term study that lasts 6 months.

She explains that 50% of the people will be given a placebo and 50% will get the actual medicine.

I asked "What if this person actually NEEDS the medicine to keep them from getting worse?".

She tells me that if the person being treated has another "medical event", then they can get the treatment they need to save their life and it will automatically opt them out of the study.

I asked "What if they have a "medical event" where they aren't close to treatment and they die, all because they should have been taking the medicine, but were actually being fed a placebo?".

She said "That's possible".

She hands over a packet of paper on it and says she'll see us later for the decision.

I sat down and read the paper work, as much as I needed to, and sure enough, there is a clause in the paper work that states that by entering the study, you could possibly be taking the risk of not getting medicine that you actually need to save your life.

So, we opted not to participate in the study. When the lady came to the room to get the answer and we told her "no thanks", she asked why and couldn't seem to understand our concerns. She said she understood, but kept trying to explain her way out of it and our way back into it.

Our decision was made, we wouldn't allow someone in our family to possibly be deprived of medicine they actually need to keep them alive and not have another serious "medical event".

I guess I never thought that they were doing trials on that level, of actually not giving people medicine they need.

What would your decision be?

it is not ethical for large companies to play games with the health of any person IMHO...especially one who is need of PROPER treatment for an illness. Google tuskegee study for a case of no ethics shown whatsoever. Big pharma still lack ethics because of the almighty dollar!

[Dan Hintz]

Google tuskegee study for a case of no ethics shown whatsoever.

..........

[Chuck Wintle]

In the Tuskegee case, the study involved actively infecting the members with syphilis under the guise of free healthcare, not handling people who had already contracted it... that's a big no-no.

The Public Health Service, working with the Tuskegee Institute, began the study in 1932. Investigators enrolled in the study a total of 600 impoverished, African-American sharecroppers from Macon County, Alabama, 399 who had previously contracted syphilis before the study began and 201 without the disease. For participating in the study, the men were given free medical care, meals, and free burial insurance. They were never told they had syphilis, nor were they ever treated for it. According to the Centers for Disease Control, the men were told they were being treated for "bad blood," a local term used to describe several illnesses, including syphilis, anemia and fatigue.

[Dan Hintz]

You're right, Chuck, my bad... memory is getting a bit soft in the old age.

[Don Jarvie]

Lets not throw the drug companies completely under the Greyhound. Drugs have saved a lot of lives, prolonged a lot of lives and kept people well and out of the hospital. 60 years ago people died from infections and rarely do today. Drug companies haven't covered themselves in glory in the past decade or so but some do great work.

As for Tuskegee, that was our government at work. Clinical trials have come a long was since then and the hoops you need to jump through with the FDA are much higher.

Just an FYI, you are allowed to take all the time you like to think about participating and always discuss any participation with your own doctor before making a decision. Sometimes you doctor may feel the trial may be worth it depending on your medical condition, etc.

[Scott Shepherd]

Just an FYI, you are allowed to take all the time you like to think about participating and always discuss any participation with your own doctor before making a decision. Sometimes you doctor may feel the trial may be worth it depending on your medical condition, etc.

That wasn't our case. It was about 5:00pm when she came in to talk about it, and she said she needed to know before she left that night, which would be around 7pm.

She came to the room about 20 minutes after our family member was checked into their room.

I don't disagree with trials or drug companies. I'm not anti-either. I just had never been faced with a decision to take medicine that could save your life or take a 50/50 chance of taking the real medicine. That's the part that struck me as odd.

I also didn't realize they were like ambulance chasers in the Emergency Room, trying to sign people up for trials. I always thought it was done outside of the ER, or at least with your own doctors advice on the subject. In the ER, you're no where near your normal doctor, so who are they trying to get to sign up? People that will make a quick decision without understanding the ramifications?

In fact, it's getting almost impossible to GET to your regular doctors these days. Since coming out of the hospital, my family member has been trying for 4 days to MAKE an appointment with their doctor to discuss it. They are talking 2-3 weeks out, which to me, seems a little crazy, but hey, what do I know?

Why wouldn't the testing company just contact the person's doctor and allow them to present the idea at their new visit? No need to hover around the ER, in my opinion.

[Dan Hintz]

That wasn't our case. It was about 5:00pm when she came in to talk about it, and she said she needed to know before she left that night, which would be around 7pm.

Something is wrong with this picture, and I would consider approaching hospital management with this situation. There should never be pressure to enter a trial, and patients should not be treated as if they were buying a car 15 minutes before they shut down the showroom for the night. You should be given at least 24 hours to think it through, and if you're put on the hot seat to make a decision, they are fast approaching lawsuit territory. Fast decisions should only be made to save a patient's life, not to get them into a drug trial before being possibly tainted with other drugs. If you need more time, ask for it... if they say 'no', ask why more time can't be allowed. If it's tainting by other drugs, that's an acceptable reason to not wait. If not, and this is a multi-year study, I can think of no valid reason why.

I also didn't realize they were like ambulance chasers in the Emergency Room, trying to sign people up for trials. I always thought it was done outside of the ER, or at least with your own doctors advice on the subject. In the ER, you're no where near your normal doctor, so who are they trying to get to sign up? People that will make a quick decision without understanding the ramifications?

The doctor should not suggest a particular trial unless they feel you are a good candidate (which was likely here, it sounds like). But yes, they will be waiting in the wings to take whomever fits the studies profile, and I don't have a problem with that (though I'm sure it feels like vultures waiting for their next meal).

[John A. Scott]

Can you add any information that may shed some light on the issue, i.e., what is the drug in question?

[Scott Shepherd]

It was Plavix.

[Stephen Tashiro]

One reason in favoring being in the trial is that the placebo effect is statistically very strong. Sometimes more people get better taking placebos than taking medicines that are known to have some effectiveness.

[John Coloccia]

One reason in favoring being in the trial is that the placebo effect is statistically very strong. Sometimes more people get better taking placebos than taking medicines that are known to have some effectiveness.

Has anyone ever considered that sugar pills are a miracle drug?

[Dan Hintz]

Has anyone ever considered that sugar pills are a miracle drug?

I volunteer to be in that trial... especially if the pills are shaped like Skittle or M&Ms.

[Don Jarvie]

Scott, The only reason for a decision so quick would be for a life threating event and the medication would need to be give within X houses. Based on what you have described that doesn't seem to be the case.

If you really want to make a big deal about it you can contact the Institutional Review Board (IRB) at the hospital. If you received a packet there should be a document called an Informed Consent. Toward the back will be contact information and the person to contact at the IRB will be listed. An IRB is a review board that reviews and approves all protocols being conducted at the hospital. They will weight the risks and benefits of the trial and factor in patient safety. All trials have risk to them but some have more than others and its the IRBs job to weigh this.

One other issue. If you had said yes your family member would not have been enrolled right then and there and given the medication. There is a screening process for all trials that goes over criteria to meet before each patient is enrolled and there would have been a formal sitdown with the study doctor or his/her representative to formally sign the informed consent and answer all questions.

Its too bad the hospital conducted themselves this way to leave a bad taste in your mouth. I work for a drug company so I know how the process works and it seems like they were a bit too pushy.

Hope your family member is doing well.
Don

[Dan Hintz]

Don,

Your response (roughly) mirrors what I sent to Steve in a PM... we weren't there, but the rep definitely appeared too pushy. Unless I'm mistaken, people can be added practically "on the spot", as it were, as long as the residing doctor is aware of all requirements for entry into the trial... this is typically done when getting someone into a trial needs to be decided in a relatively short period of time, but again, long-term trials rarely need this sort of instant access. The whole situation smells...

[Dave Anderson NH]

One issue which hasn't been directly addressed here is financial incentive. In many clinical trials the hospital, a particular physician or group of physicians, or both have a vested interest in signing up the participants and getting a study going quickly. This can be and ofen is a major income producer and the money is paid out to the people or organization running the study. These studies are not done out of the goodness of anyones heart, there is serious money to be made. This is not to say that studies are not useful or needed, but rather the motivation should be in the back of people's minds.

7 years ago my wife had a minor heart attack and was taken by ambulance to a quite good community hospital. Testing and diagnosis determined that she should would likely need to be stented based on the results of an angiogram. The attending cariologist (not her own ) came in and tried to convince us that the angiogram shold be done there and that if the results indicated the need for stenting, she would then be transported 1/2 hour to the Heart Institute at Catholic Medical Center in Manchester NH. The doctor, who practicied at both hospitals, and was a member of the group that would take care of things at CMC if needed, was forced by hospital politics to push for a local angiogram. On my advice, Sue refused. 15 minutes later the female top hospital administrator was in her room very very agressively pushing for the proceedure to be done there. We again refused and the administrator left in an obvious huff. It was all about income for the hospital and any extra risk or pain and suffering by the patient was not something they cared about. If we had allowed them to push, Sue would have ben catheterized in the femoral artery and transported via ambulance with her leg sandbagged while she was in only minor pain as long as the leg didn't get bumped, the ambulance didn't hit bumps in the road, and there were no traffic jams or delays.

The bottom line is that you have to know both the medical side of the story and the know the motivations of the people involved. Follow the money.