Ethics of Chelation Study Questioned

Early findings from a federal investigation suggest that there may be ethical problems with a large-scale study on chelation therapy, an alternative treatment in which chemical compounds are injected into the blood. According to the report from the U.S. Office for Human Research Protections, researchers did not properly inform the participants of potential health risks. The probe also revealed that some of the researchers have been disciplined by state medical boards, and at least three are convicted felons.

Despite these findings, the trial is allowed to continue during the ongoing investigation.

The controversial study initially began in 2002 to test the effects of EDTA (ethylenediamine tetraacetic acid) chelation therapy and high doses of vitamins and minerals in heart attack survivors. Researchers hypothesize that this therapy may help break down cholesterol plaques that cause clogged arteries by binding to calcium and other minerals.

Although chelation therapy with calcium-disodium EDTA and dimercaptosuccinic acid (DMSA) are approved by the U.S. Food and Drug Administration for lead poisoning, there is currently a lack of evidence that any type of chelation therapy is safe and effective for heart disease.

The trial was voluntarily suspended in August 2008 when the U.S. Office of Human Research Protection first questioned whether participants were fully aware of the health risks. Chelation therapy has been associated with numerous adverse effects, including allergic reactions, severe kidney damage, bone marrow problems, dangerously low blood pressure, dangerously low calcium levels in the blood, increased risk of bleeding or blood clots, immune reactions, irregular heartbeat, blood sugar imbalances and convulsions. Death has also been reported, although it is not clear if chelation therapy was the direct cause.

Just one month earlier, in July 2008, another chelation study was also halted due to potential safety concerns. This study aimed to test the effects of chelation therapy in autistic children. The National Institute of Mental Health (NIMH) cancelled the study after a rat experiment found that the therapy may cause brain problems.

In early 2009, the researchers once again began recruiting participants for the heart disease trial. So far, the $30 million study, which is funded by the National Heart, Lung and Blood Institute and the National Center for Complementary and Alternative Medicine, includes at least 1,500 participants.

For more information about chelation please visit Natural Standard’s Health & Wellness database.

Comments

[Iggy]

16 years ago at age 75, my mother developed macular degeneration. She was diagnosed shortly after her 1st car wreck. Her ophthalmologist told her she was almost totally blind in one eye and the other eye appeared to be deteriorating fast. He told her to prepare for total blindness, and there was no effective treatment.

I talked Mom into heavy supplementation with vitamins and herbs, including lutein and zeaxanthin. She also commenced IV chelation treatments.

In a few months, her ophthalmologist told her that her macular degeneration had reversed and for her to continue whatever she was doing. When she tried to explain her self-treatment, he quickly changed the subject. After a year, he told her he could no longer find any trace of macular degeneration.

Her local small town family physician found out about her chelation treatments and kicked her out of his practice. She had to switch to an immigrant doctor.

Today, at age 91, Mom's vision is good and she's still driving and living alone independently.

[Regina]

Reading about these researchers who failed to properly inform their patients of the health risks involved in using chelation therapy for heart disease made me think of my own experiences during pregnancy and childbirth. Before any invasive medical procedure, a patient is often asked to read about all its potential side effects. These can be quite scary and may even discourage one from undergoing the procedure. In my own case, although I was not discouraged from receiving an epidural during labor, I did decide to opt out of amniocentesis after hearing about all the risk involved, however small. It may seem sometimes that one is better off simply not knowing about everything that can go wrong. However, knowing that one’s doctor may withhold information, especially for a procedure whose safety has not yet been proven (such as the use of chelation therapy for heart disease) seems a lot scarier.

[Annie]

I have read Iggy's story above, and several other similar reports on various Web sites and postings. The discrepancies between the dangers and adverse effects and the anecdotal evidence are confusing, although I imagine it is largely due to the fact that these individual stories are not controlled studies where other intervening factors are screened out?

On another note, it's disappointing to hear of these ethical issues, which will only tarnish the image of alternative and complimentary approaches to treatment.

[Grace]

I'm happy to hear that chelation therapy has been able to help some people, and I think this warrants more research, but the research conducted must adhere to all the policies and procedures that are in place. If chelation therapy is to be studied and taken seriously, then the study must be conducted in a reliable manner that also upholds its ethical duty toward the subjects.

[Melinda]

Am I the only one that is surprised that a $30-million-dollar study had convicted felons on the research team?! It may be the case that whatever they were convicted for bears no relevance to the study, but some of the researchers also had issues with state medical boards. Isn't there some sort of guideline that would prevent researchers from conducting studies with subjects if they have such records?

[Cathy]

While doing a quick search on EDTA, I found that in addition to its use as a chelating agent, it is also used in a wide variety of applications -- from industry, to food additives, to household products. It is apparently so widespread that it is causing environmental concerns. It seems to enhance the bioavailability and mobility of heavy metals in the environment, thus leading to bioaccumulation of toxic metals in the food chain.

I agree with Melinda regarding the study..I was very surprised to hear about felons and medical board offenders being allowed to conduct the study.

[Lauren]

Nope Melinda, you are not the only one. I too was a bit surprised to read that convicted felons were running such an expensive research endeavor. You would think that that little fact might raise some red flags with whoever was funding the study.

[Farid]

I thought before a study is approved, it has to go through IRB (institutional review board) process, in which people review the study protocol and also check the appropriate consent form for the patients. So I think before these study were conducted, they have been reviewed by the IRB from the institution. Well, about the chelation therapy for the heart disease: I don't think it's appropriate b/c there is no evidence to use chelation therapy for heart disease.

[Terance]

I agree. Based on the numerous adverse effects already associated with chelation therapy, it does not seem very appropriate to try in patients with pre-existing heart disease. It is strange that another study is being attempted on this topic; it seems there are better areas of research that money could be spent on in regard to heart failure.

[Iggy]

I'm not sure the chelation helped my mother. I'm more inclined to believe the supplements are what helped. Mom was likely influenced by the dozens of enthusiastic fellow chelation patients that claimed they could not walk before beginning their therapy.

[Estelle]

I'd have to agree with both Melinda and Lauren. As soon as I read this article about chelation therapy and that the researchers were either convicted felons or disciplined by state medical boards, I thought to myself, "how is that even possible??" There should most definitely be rules and regulations regarding who can conduct such large-scale, expensive studies. Regardless, this study should be halted during the investigation, especially if participants were not fully aware of the health risks.

[asr]

Farid, I was also under the same impression. Since this is a 30-million-dollar study, you would think that the study would be fully reviewed prior to its initiation. Also, it is being funded by the National Heart, Lung and Blood Institute and the National Center for Complementary and Alternative Medicine, both of which should have looked into what the study entailed before providing funding. Can they also be held responsible if some sort of legal issues arise?

[Kiera]

According to the NS monograph on chelation therapy, the level/quality of evidence for its use for heart disease is a "D." So, if this study had been conducted properly, abiding by current clinical study guidelines and regulations, it could have provided better data to further evaluate the use of chelation therapy for heart disease. It's unfortunate that this will be another study that doesn't really clear up any "gray" areas regarding chelation therapy.

[Rudy]

Wow, it sounds so scary to have this chelation therapy done to a lot of people, but I think for some people, maybe this is the only choice to cure their disease. It's a dilemma either to experience the adverse effects or to have the disease cured. Maybe for some people, the chelation therapy works, but for others, it could be dangerous. Chelation therapy itself sounds pretty scary to me because I feel like the doctor will inject pretty toxic substances into my veins, and I don't know how my body would react to it.

[Summer]

With the large amount of safety concerns and the lack of evidence in support of this therapy, I would be hesitant to participate in such a study or even use chelation therapy. But I suppose if it was the only option available, my thoughts may be different. Regardless, participants should be fully informed of any potential side effects of the therapy being investigated, especially since other studies have been stopped due to the risk of detrimental side effects.

[bbm]

I'm curious about exactly what these patients were told when they entered the study. Obviously, the ethics of a convicted felon are suspect, but wouldn't the patient ask a million questions before giving up their body to science? Was there any type of consent form signed by the patients? Sometimes I question the integrity of the scientific process. I think that if this study is completed or a new one is started, the results could be very beneficial. But even when it is published, I'll wonder how honest and unbiased the authors were. They were willing to hide information from the participants, so what are they willing to hide from us?

[HM]

I disagree with the idea that a patient would likely ask a lot of questions before starting a scientific trial. Many patients who enroll in trials are most likely at the end of their ropes and have no other option to go to for therapy and for resolution of their illness. It is the responsibility of the researchers and scientists to disclose significant adverse effects as was found with chelation therapy with EDTA, such as kidney damage, hypotension, bleeding and convulsions. To be deceptive about such important information makes one question the integrity of future studies and publishing that these researchers might engage in.