Every day, Americans join clinical trials that test promising new medical procedures, pharmaceuticals, and other therapies for a range of health conditions and diseases.
The clinicaltrials.gov website, for instance, lists over 400 studies on aspirin and disease prevention alone, and more than 1,200 on diabetes treatments.
But many people who sign up for clinical trials may not know there are significant risks and caveats. It’s buyer beware because what you get into may not give you the best results for your health condition.
Clinicaltrials.gov does have a disclaimer on its website, but because 600 new trials are added every day, there is no way to vet every study. The site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health.
All clinical studies should have an institutional review board, and patients are encouraged to discuss their participation with their own healthcare provider.
For three women in southern Florida, this would have been a wise course. They each paid $5,000 to join a trial looking at whether stem cells injected into their eyes would help with macular degeneration. Before the procedure all the women had some vision loss, but could see well enough to drive. One went completely blind and the other two lost much of their eyesight after injection of stem cells.
The case spotlights the potential risks associated with clinical trials, which are designed primarily to test new and experimental therapies — NOT necessarily to cure or help participants in those studies.
Stem cell therapies, in particular, are very popular right now, cautions clinicaltrials.gov.
“People want it to be the Holy Grail – stem cells are like that,” a representative at clinicaltrials.gov said. The Food and Drug Administration doesn’t regulate all trials involving stem cells because they are not medication.
Administrators at clinicaltrials.gov and the FDA strongly recommend that before you enter into a clinical trial you clear it with your own healthcare provider.
U.S. Stem Cell in Sunrise, Fla., the clinic that did the eye injections, didn’t need FDA approval because the patients were receiving their own stem cells. The cells were harvested from belly fat, and then injected into the patients’ eyes. In this case it is suspected that the cells had grown onto the retina and then contracted, pulling it off the eyeball.
U.S. Stem Cell no longer does any eye procedures. Since 2001, U.S. Stem Cell successfully conducted more than 7,000 stem cell procedures with less than 0.01 percent adverse reactions reported. Company officials declined to comment further about the recent case.
The FDA won’t comment on any existing investigations, but the agency posted a Consumer Update — “FDA Warns about Stem Cell Claims” — and encourages consumers to report any illegal or harmful activity related to stem cell based products.
According to Andrea Fischer, spokesperson for the FDA, some legitimate studies do charge a fee, although many cost nothing to the participant.
The FDA provides a lot of guidance for people who may want to participate in a trial.
Among the most common consumer questions and answers:
What is available through clinicaltrials.gov?
There are 240,374 records, with 41,739 recruiting participants now. You can search for open clinical trials and browse by category, condition, or location on the website.
Studies are sponsored by the National Institutes of Health, other federal agencies, nonprofit organizations, and private industry.
Should you join a clinical trial?
Ask your doctor first. You will want to know about possible contraindications of medications or procedures.
Find out how risks of the new treatment might compare with whatever you are doing now.
Ask about tests, procedures and hospitalizations
Ask whether you will you pay, volunteer, or be reimbursed for joining any trial.
Find out the goals of the researchers: What are they trying to prove in the trial?
If the intervention works for your condition, determine ahead of time if will you be able to continue the treatment.
For more information: check out the FDA Website.
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