Advocates hope new health law will encourage more participation in trials
Article Source: msnbc.com
from:msnbc.comPatients in clinical trials to get routine care covered
Seeded on Thu Aug 26, 2010 10:08 AM EDT (msnbc.com)
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What about medical research studies designed to learn more about a particular disease or rare condition?
Lots of tests and consultations may be necessary, but no new treatment or drug is tested. Insurance may already cover these patients because it is likely more will be learned about the patient's condition and therefore help future treatment. If not covered, they should be.
Clinical trials are often a helpful way for poor or uninsured patients to get outstanding FREE medical care, at least during the specified duration.
NIH-funded studies designed to learn more about a condition or disease include compensation for the study participants for things like travel, and the researchers are required to provide any medical treatments or services associated with the study at no cost to the patient. Other funding sources generally use the NIH guidelines. Other than baseline activities such as getting a serious physical or other tests related to the condition being studies, it is NOT a good way for poor or uninsured people to get medical care. This is especially true since most clinical trials are "double-blind" and neither the physician nor the patient knows whether they are receiving a drug or treatment, or are getting a placebo or sham treatment.
Except for end-of-life clinical trials, most clinical trials are conducted overseas, primarily in China, India, and Bangladesh. This is because the clinical "atmosphere" there is more lenient and study participants tend to give "more positive results" than American participants. One of the dirty little secrets of the drug industry is that in at least those three countries there are schools which teach prospective participants, usually rural uneducated poor, what to say in order to get into a particular study and what not to say. Many "professional" clinical trial participants enroll in several clinical trials under several different names concurrently as a way of earning a living. A good example is Gardasil which was intended for young girls was primarily tested on elderly Chinese men.
End-of-life trials are a different situation. Usually the patient cannot travel to participate in trials and must be treated in the hospital or hospice where they already are. In most cases they have little to lose because they are already terminal. But insurance companies have held up a lot of this research, especially in the case of cancer and heart disease by refusing to pay for ANY medical charges if the person participates in a clinical trial.
And it is not quite fair to ding insurance companies too heavily for this because they don't want to pay for experimental treatments which probably will not do any good. And insurance companies are also concerned that they will end up paying for the side effects of such treatments.
I will tell you one first-hand story from a number of years ago. I participated in one of the initial h. campolori and ulcer clinical trials. It worked very well for me. But at one point I was chatting with another participant *which you are not supposed to do) and the other guy told me that he was getting the placebo instead of the "real" treatment. I asked him how he knew and he replied, "No side effects."
I am a RN currently managing a clinical trial program. I think that you are misinformed regarding most everything you stated about clinical trials in the US. NIH studies are not run in the same fashion as the pharmaceutical companies studies. The studies that we have through the NIH for cancer treatment do not pay the person to participate or compensate them for travel or anything else. They simply supply the medicine being investigated and the patient or their insurance is responsible for the cost of everything else. The provider is not required to offer any treatment related to the study at no cost. This would detour many physicians from participating in clinical research. As for the "sham treatment" that you speak of, in dealing with treating cancer patients, there are placebo treatments but only if the patient is receiving the standard of care treatment for that specific cancer. We never treat with either medicine or placebo alone unless there is no known treatment for the cancer.
As for most of the clinical trial being done outside of the United States there are a large number of clinical trials that are done here in the US. Any trials that are done outside of the US, by an American company, the foreign counterparts must meet the American standards in order to participate. These trials are very closely monitored. The results of these trials can mean life or death for patients and it is of the upmost importance that the treatment given is standardized across all treatment facilities.
I am very disappointed in the center that you were treated at if they asked you not to talk to one another. I have worked in two different clinics, in research, and we never told our patients not to communicate with each other.
It's only because of clinical trials that we have any drugs to fight cancer on the market today. Ignorant comments like yours make it even harder to recruit participants to these life-saving trials.
Shame on you!
Chris I think you are very wrong. My little daughter has a brain tumor, benign thank god but inoperable and therefore recieving chemo... many of the children on our list serve are / have participating in clinical trials, most of them are here in US and they are very very aware of what treatments they are receiving. They are all NIH trials. We signed paperwork for my daughter to be included in Phase 4 study which basically compares effects of two different known, standard care drugs. Many of the kids with aggressive or non-responsive tumors have done Phase 1 trials. You don't get 'placebo' drugs with cancer, that would be malpractice. The closest situation would be the phase 4 trials where the doctor tells you, there are two protocols used for this disease, here are the pros and cons of each, there is a large study comparing the for long term results, which one do you want to go with? It's not like they give you sugar pills while some other person is getting the "real" treatment. That's silly. Perhaps they do that with conditions like acne or weight loss drugs or something; believe me they are not doing that with cancer. If my baby girl fails the traditional 1st and 2nd line treatments, we will look for clinical trials in earlier phases that might help. Unfortunately for us, there are not a ton of pediatric brain tumor trials to choose from and they all require tissue samples (her location is not biopsied unless there is concern for malignancy).
What???? Are you kidding me???? 2014!!! Why wasn't this pushed to be effective immediately or at the very latest 2011?! How would all those lawmakers feel if it were their family, not being able to participate in a trial that may make a difference in living or dieing, all because the insurance companies may deny their coverage? One step deeper into unaffordable health care in this country; of course if you're wealthy I guess it doesn't impact you, now does it?
Millions of seniors on Medicare will lose their current source of drugs in 2011 and will have to change to a new supplier for their drugs. There has been no media coverage on this due to politics. Of course the announcement will come after the November elections.
AKA, people will have to change from brand name to generic versions of the same drugs. That only means that they won't have to keep paying for the R&D that has already been fully covered multiple times. It's no big deal. THERE IS NO DIFFERENCE IN THERAPEUTIC VALUE. Stop fear-mongering.
I love me some generic drugs! My insurance company pays almost the entire cost of those, versus only a small portion of the name-brand. Get the facts, people. Quit spreading mis-information.
Chris - where did you get your information about the overseas clinical trial "schools"?
First let me say that I have problem whatsoever with the idea that anyone participating in a clinical trail for a potentially lifesaving drug should have the rest of the medical costs covered.
But this is my question - why is this restricted only to life-saving drugs? There are plenty of illnesses that have huge negative but non-fatal implications for the lives of the patients. If you are one of those patients, and you are in a clinical trial of a drug that may improve your life to the point that you can get your old life back, why should you, too, not have the rest of your medical expenses covered during the course of your trial?
This article (and some of the comments) skews facts about clinical research. Research is just that, an experiment. It may or may not help participants. As a matter of fact, it could make them worse. We don't know and that is why trials are done, to find out more information.
I work for pharma companies and literally millions of dollars are spent for development. For participants in trials, ALL of the procedures related to the study are paid by the sponsor. Extra blood work, x-rays, gloves, dressings, exams are paid for by the pharma company. It is ridiculous for insurance to refuse to pay for routine care not related to the study. A diabetic patient will still need glucose tests and insulin regardless of whether they are in a study or not. If there are side effects requiring treatment, the sponsor pays for that too. Of course, it depends on that "side-effect" and the cause. By the time patients with the condition the drug is supposed to treat are being given the drug, the company has much information about the expected side effects. If you have a history of seizures and have a seizure during the study, it could be argued that the seizure is not related to the experimental drug and therefore the sponsor should not pay for treatment related to the seizure. If the experimental drug is known to cause seizures and you have a history of seizures, you would be excluded from being in the trial to avoid potential problems and confounding results.
This article (and some of the comments) skews facts about clinical research. Research is just that, an experiment. It may or may not help participants. As a matter of fact, it could make them worse. We don't know and that is why trials are done, to find out more information.
I work for pharma companies and literally millions of dollars are spent for development. For participants in trials, ALL of the procedures related to the study are paid by the sponsor. Extra blood work, x-rays, gloves, dressings, exams are paid for by the pharma company. It is ridiculous for insurance to refuse to pay for routine care not related to the study. A diabetic patient will still need glucose tests and insulin regardless of whether they are in a study or not. If there are side effects requiring treatment, the sponsor pays for that too. Of course, it depends on that "side-effect" and the cause. By the time patients with the condition the drug is supposed to treat are being given the drug, the company has much information about the expected side effects. If you have a history of seizures and have a seizure during the study, it could be argued that the seizure is not related to the experimental drug and therefore the sponsor should not pay for treatment related to the seizure. If the experimental drug is known to cause seizures and you have a history of seizures, you would be excluded from being in the trial to avoid potential problems and confounding results.
I lost medicaid for good,because my Daughter turned 18. I know I can't afford to watch for regrowth now. I survived astrocytoma grade 2. I need MRI's every 8-12 months and EEG's sometimes. I also have to take lamictal for seizures.. I've written to Oprah, Dr Phil other talk shows and the news and I guess they don't have time to help.
I work part time as an afterschool program lead teacher. Its becoming more of a challange I have short term memory trouble, headaches. Auras and twitches sometimes. Have'nt had a big seizure for 2 years. I am scared though. I don't know how I am going to afford to live. I'm only 42. SOS
Bonnie Jean