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Old 01-16-09, 11:18 AM   #1
Yen
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OT: Invited to participate in vaccine research study

I received an invitation from the City of Hope (one of 40 National Cancer Institute-designated Comprehensive Cancer Centers, this one located in Duarte, CA) to participate in a clinical research study to evaluate a vaccine for Cytomegalovirus (CMV), "a very common infection that doesn't typically affect healthy people" (however is "deadly" serious for certain other groups).

I meet all the requirements:
-- 18 to 55 years old and in good health (I'm 52 and in excellent health)
-- Not currently taking any medications for chronic illness or infections (I take no meds)
-- Not recovering from a major surgery in the last 6 months (no major surgeries)

The card was addressed to me, I believe because I'm on the bone marrow donor list.

Participants are paid $75 for each of 13 visits over the course of one year for:
-- 4 vaccine shots over 9 weeks
-- A series of blood samples collected over the course of one year. The blood is used to determine vaccine response.


I'm very interested in participating, and I can't think of a good reason not to. City of Hope is not far from me, about halfway between home and work. It's an opportunity to help others. And, oh sure, the $975 would really come in handy. However, I know nothing about these studies and the outcome of the participants -- could the vaccine cause any harm?

About CMV: http://www.cdc.gov/cmv/
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Old 01-16-09, 11:21 AM   #2
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I wouldn't let anyone poke an unkonown - or "to be tested" - vaccine in my body.

I remember all the folks who got Guillain-Barré syndrome from a supposedly safe Swine flu vaccine about 30 years ago.

http://www.cdc.gov/FLU/about/qa/gbs.htm

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Old 01-16-09, 03:06 PM   #3
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.....
I meet all the requirements:
-- 18 to 55 years old and in good health (I'm 52 and in excellent health)
-- Not currently taking any medications for chronic illness or infections (I take no meds)
-- Not recovering from a major surgery in the last 6 months (no major surgeries)
.....
All good reasons not to participate. Think back over the last ten years about how many dangerous though approved drugs have been pulled off of the market due to serious (life threatening / ending) side effects?
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Old 01-16-09, 03:35 PM   #4
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YIKES! No one here can give you an answer to that question.

If you're planning on coming down with a serious immune deficiency like CLL or any number of things requiring chronic therapeutic immunosurpression, then a CMV vaccine is a great idea. If it works.

We vaccinate for all sorts of other viruses with only rare serious side effects. But they are possible.
I'm sure all the other vaccines went through similar trials.

When I was in training, and before we had anti-viral therapy of any kind (crap, sometimes I feel like I was trained before we had penicillin), I saw a man with CLL die of overwhelming CMV. I remember it to this day. So, when we get a good vaccine for CMV I'll be first in line for it.

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Old 01-16-09, 04:24 PM   #5
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There have been several reports of adverse effects on people taking part in Drug tests over here. The risk may be very small as to having that adverse effect- but it is there.

And as To taking part- While I was waiting for the Bypass- I participated in a drug test. When it came to the bypass- I went to the hospital and they realised I was on this test. They checked it out and I was lucky- I was on the placebo so I could have the Bypass. Those that were taking the actual drug had to wait 4 weeks off the drug before any surgery.
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Old 01-16-09, 04:32 PM   #6
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I wouldn't do it. And it seems to me that $75 is a paltry sum of money for each trip. Make it ten times that and I'd do some serious investigation into it. I suspect the pharmaceuticals could afford to underwrite any study such as this at that level.
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Old 01-16-09, 04:46 PM   #7
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Guinea Pig.

It's a gamble. You might get bad drugs, you might get good drugs or you might get no drugs at all.
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I don't care if you are on a unicycle, as long as you're not using a motor to get places you get props from me. We're here to support each other. Share ideas, and motivate one another to actually keep doing it.
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Old 01-16-09, 06:06 PM   #8
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Thank you for your honest comments; that's enough for me. I've never been a drug user (never even experimented, hehe!) and still don't like to take even an aspirin or Advil unless I REALLY need it or my life depended on it. I chose lifestyle changes over pills to fix acid reflux (people actually asked me "wouldn't it be easier to take a pill?") So, no thanks to the study.
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Old 01-16-09, 06:53 PM   #9
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Guinea Pig.
A.K.A. Cuy, the national dish of Peru.

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Old 01-16-09, 07:05 PM   #10
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Did you ever hear the disclaimer for medicines in TV commercials such as - may cause nose bleeds, hypertension, dizziness and even death - they have the disclaimer because someone in their study had such a reaction. Don't let it be you.
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Old 01-16-09, 09:06 PM   #11
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For me, the risk/reward ratio is way out of kilter.
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Old 01-16-09, 09:47 PM   #12
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Did you ever hear the disclaimer for medicines in TV commercials such as - may cause nose bleeds, hypertension, dizziness and even death - they have the disclaimer because someone in their study had such a reaction. Don't let it be you.
The study is to test a vaccine, not a drug. Isn't there a difference?
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Old 01-16-09, 10:23 PM   #13
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Do it for the rest of us!

They run similar trials frequently here in Madison. I find it interesting that healthy people will subject themselves to unknown medication and significant inconvenience (multiple trips to a clinic, shots, examinations, etc) all for $500 or $700 or $900.

If you grow a second head, it will cost a lot more than that to remove it.
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Old 01-16-09, 11:19 PM   #14
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If you grow a second head, it will cost a lot more than that to remove it.
...And you can get a 2nd helmet for under $100.
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Old 01-17-09, 02:16 AM   #15
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...but if she grows a second pair of legs instead she'd have to buy a tandem. Very $$$$.
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Old 01-17-09, 03:55 AM   #16
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The study is to test a vaccine, not a drug. Isn't there a difference?
Yes there is, the purpose of the vaccine is to build up your antibodies against a certain danger. The closer the vaccine is to the actual danger, the better the vaccine. For example, Smallpox. The vaccine was dead Smallpox. The same with Polio.

Here's a quote from Wikipedia about the Polio vaccine...
"In 1936, Maurice Brodie, a research assistant at New York University, attempted to produce a formaldehyde-killed polio vaccine from ground-up monkey spinal cords. "

So a danger doing vaccine testing is that you could actually catch the disease because of the testing. Fortunately, we will assume that they test your blood sample against the real disease, rather than injecting you with it.
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I don't care if you are on a unicycle, as long as you're not using a motor to get places you get props from me. We're here to support each other. Share ideas, and motivate one another to actually keep doing it.

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Old 01-17-09, 08:57 AM   #17
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Tom B is correct. you are doing it for the rest of us rather than for yourself. One of the biggest problems in developing new drugs and vaccines is the expensive testing of thousands of individuals with close following and documentation of every little thing that might happen. Horribly expensive, then we complain of the high cost of drugs and the holdup of new drugs by the DFA! And yes, price gouging is definitely there, too, so I'm not defending drug companies.
Historically, some of the side effects of drugs and vaccines have arisen because they haven't been adequately tested. But how many volunteers do you need to 'adequately test' a new drug or vaccine? And how do you get them signed up? Everybody has the attitutde "Not me, let the other guy do it!"
Regardless of testing numbers though, you will never know of many rare side effects or complications of many drugs until you actually prescribe it for tens of thousands of people, hundreds of thousands, actually. Then, when some rare complication is finally identified and the drug may or may not withdrawn, everyone yells and screams "Inadequate testing, etc.!"
In some ways you can't win. Not that I'm protecting any drug companies, just trying to explain that bringing on board a new drug is difficult and expensive. To put things in prospective, had Aspirin been developed now instead of a century ago it probably never could be approved! Way too many side effects, especially for over the counter sales! And if so, it would have required 10+ expensive and difficult years of testing and documention. So Yen's decision as far as I'm concerned is a personal one, not for me or anyone else to get involved in.
I'm glad you are on the marrow list. This is another thing that everyone says "No Way! Let someone else do it!" Yet, if catastrophe strikes, they sure want the transplant, and right NOW, too! Like everyone wants a new magic wonder drug, and right now, too! Hah!
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Old 01-17-09, 09:54 AM   #18
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Thanks so much for your additional input.

On one hand, since CMV apparently (according to what I've read so far) isn't life-threatening for healthy people like myself, I might go through the study unscathed. On the other hand, I might not, and I consider my excellent health a blessing not to be gambled with.

bobkat's point about aspirin reminds me of a story about my Grandfather. Back in the 1940s, in the small town of Fillmore, CA, he was badly burned in a fire at the oil refinery where he worked. At that time, a local family was making a sulfer-based ointment called Hydrosulfasol as a treatment for burns. The local hospital used it to treat the burn victims. In spite of my grandfather's 3rd degree burns, I do not recall the typical physical disfigurement caused by deep burns, other than some loose skin on his arms. In addition, his recovery was much faster than normal.

Years later, when I first learned about the story in Fillmore's centennial(?) yearbook, I became very curious about whatever happened to the medicine and why it was not approved as a conventional burn treatment. On a lark, I called the City of Fillmore. The Fire Chief answered the phone (as I said, it's a small town) and I shared my story. He knew of the ointment and told me his own story about how it very quickly healed a burn he sustained in a heater accident. Amazingly, he put me in touch with the daughter of the family who made it, now an older adult. She shared more stories about Hydrosulphasol's amazing healing affect on skin burns. I asked her whatever happened to it -- just think of all the burn survivors who might have benefited!!!!

She told stories of her efforts to get it marketed. She'd gone all the way to the top of the FDA, but could not get it approved. She gave me the name and phone # of a woman whose husband had also benefited from the ointment and was working on a campaign of her own.

I contacted that woman, but it was clear she was in it for the money. She wouldn't share information with me and talked to me as if I was a child. So, I let it go.

So, I know first-hand that there's AT LEAST one drug out there with truly amazing healing effects that would have benefited many, many people -- but could not get through the pearly gates of FDA approval.
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Old 01-17-09, 10:58 AM   #19
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I wouldn't let anyone poke an unkonown - or "to be tested" - vaccine in my body.

I remember all the folks who got Guillain-Barré syndrome from a supposedly safe Swine flu vaccine about 30 years ago.

http://www.cdc.gov/FLU/about/qa/gbs.htm
That(swine flu) was next to the last vaccine I got. The last one was when I still lived in the northeast, and Lyme disease is widespread. I spent a lot of time mtn.biking, so when the Lyme vaccine came out, Donna and I both were vaccinated. It's now off the market-something about a protein in the blood, that if you had the protein and got the shot, it could contribute to rheumatoid arthritis (or something along that line). It is now off the market. No more vaccines for me. I'm lucky in that I've never had a reaction or problem with them, but looks like I dodged two bullets already, and I'm not ready to chance a third one!
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Old 01-17-09, 11:08 AM   #20
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For purposes of full disclosure, I was a member of UCLA's institutional review board (IRB) for several years. The IRB is a body formed under federal law that is responsible for protecting the rights and welfare of human subjects. Research protocols like the CMV vaccine study would have been reviewed and approved by the City of Hope IRB. I now work in the biotech field and also appreciate the value of well designed, scientifically valid, ethical research and the need for clinical research participants to develop therapies to meet unmet medical needs.

That said, you don't know enough from the recruitment material to say you can't think of a reason not to participate. If you are interested, follow through with the initial visit and carefully discuss the informed consent - especially the risks and benefits - with the principal investigator (study doctor). Then take time to discuss with your family, your medical doctor (not the bikeforum folks).

It is essentially a risk:benefit analysis. Here, there is likely no individual benefit to you (the majority of adults in the US have already been exposed to CMV and have developed antibodies), but by taking part in the study you are benefiting society (some people do participate in clinical trials for purely altruistic reasons).

As a "healthy volunteer", the risk:benefit analysis is tricky. There is clearly more than minimal risk to the CMV vaccine study. Once the vaccine is in your system, you can't remove it (in contrast, you can stop taking a drug and the body will rid itself of the drug over time). Also, do NOT consider the $$ compensation as a benefit. That is simply intended to compensate you for your time and inconvenience. Also, look at the informed consent to see if the study sponsor or City of Hope will reimburse you or pay for any injuries you might get as a result of your taking part in the study. By law, this information will be in the informed consent.
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Old 01-17-09, 11:56 AM   #21
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The study is to test a vaccine, not a drug. Isn't there a difference?
Rent the movie "Whiff", which convinced me to not participate in studies offered by the Veterans Administration. Though medical treatment at the VA has improved immensely I still wouldn't participate as part of a "Trial". It didn't kill the rats so maybe it won't hurt us humans, but you never know.
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Old 01-17-09, 04:46 PM   #22
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Would this still be OT if she rode her bike to the follow-up visits? how about if she used the cash to buy bike gear?

I was a research coordinator for experimental drugs for several years. Still am involved in research. I've spent a fair amount of time quaking before IRBs like Velodiva's.

You would be amused at the things that I've had to report as possible side effects just because the volunteers forgot to mention it before they started the trial ( use your imagination here). Yet, serious or significant effects can be hard to catch if they occur rarely. Any serious event has to be reported immediately to the FDA and an IRB.

Once had the son of a study patient offer money, call the hospital board chairman, and call every MD he know in an attempt to get his Dad the experimental drug for sure instead of the control. Turned out the experimental drug was ineffective.

Good points made both pro and con above. In the end, you've got to go with your comfort level. There is no wrong choice here.
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Old 01-17-09, 05:34 PM   #23
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The study is to test a vaccine, not a drug. Isn't there a difference?
Yes, my understanding is that a vaccine for a given bacterial disease gives you a small amount of the bacteria, small enough that your body will build antibodies to that bacteria. You are actually given the disease to teach your body to defeat it.

Maybe you should talk to your doctor about safety.

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Old 01-17-09, 06:03 PM   #24
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A vaccine is still considered a drug, though, and needs to be tested for safety and efficacy just like any other.
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Old 01-18-09, 11:39 AM   #25
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I certainly wouldn't partake in the study solely on the advice of the BF members. I have nothing to risk by going to the initial screening and asking questions, then talking it over with my doctor. In the end, my decision would be based on a combination of my acceptance of the risk factors, and the opportunity to help others. It's a serious decision and I wouldn't want to jeopardize my good health for any of the wrong reasons.

Oh -- thank you all for your enlightening input. My original question wasn't to ask "Should I do it?" -- I realize this isn't the place to get the final answer. I hoped for feedback on things to consider, and perhaps experiences by others who've participated in similar studies. You made some points that may not be mentioned me by my doctor or even by the PI.
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