When facing an illness, you might turn to a clinical trial for treatment that isn’t available eleswhere. The best place for patients to find trials is the site ClinicalTrials.gov, which is a site administered by the National Institutes of Health and is exactly what it sounds like. The site has trials where researchers are testing experimental drugs or procedures that may help them. The problem is that not all “clinical trials” are exactly what they seem.
Specifically looking at trials for treatments involving stem cells, a new article by Leigh Turner of the University of Minnesota Center for Bioethics in the journal Regenerative Medicine explores how for-profit clinics looking for paying customers can exploit the site and its listings, leading patients to think that a listing for a “patient-funded” clinical trial is a government-endorsed clinical trial.
Why would I look for clinical trials?
A clinical trial is when researchers try new medical treatments on real humans in a clinical setting: A doctor’s office or a hospital. Depending on the clinical trial’s structure, you also might receive the new treatment, the current standard treatment, a placebo, or no intervention at all. (Yes, even placebos for surgeries exist. They’re controversial.)
For most clinical trials, patients do not have to pay for treatments or medical visits. That’s part of the appeal of taking part in a trial: You may receive a cutting-edge medication at the expense of the drug company. Or you might not be in the group that receives the cutting-edge treatment.
ClinicalTrials.gov now carries a disclaimer, warning that “Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations.”
Some of those laws and regulations include charging patients for drugs and devices that are regulated by the Food and Drug Administration, and which have not yet been approved. Hospitals and clinics are not supposed to profit off their patients in a clinical trial, but they can charge something for “cost recovery” with the permission of the FDA.
The ClinicalTrials database asks the trial sponsors whether a clinical trial has been approved by the institution’s institutional review board, if necessary, for experiments performed on humans.
Where do the stem cells come in?
Stem cell clinics say that they are simply filtering out patients’ own cells and putting them back in the body, and this is considered a medical procedure and not a drug. The FDA has not been aggressive on pushing this point, but should the ClinicalTrials.gov database? 1
The most notorious example, which made news around the world and led to the site adding its disclaimer, was the case of three women who paid thousands of dollars to take part in a stem cell clinic’s “clinical trial” to treat age-related macular degeneration, an eye disease.
At least one of the women found the “study” through ClinicalTrials.gov, and thought that it was a legitimate government-approved trial. Instead, all three patients received injections of stem cells processed from their own fat. Both eyes were injected on the same day, and all three patients lost their sight from the treatment.
“The development of robust screening tools that review whether submitted studies are compliant with regulatory standards concerning oversight of human subjects research and the administration of stem cells is necessary to prevent ClinicalTrials.gov from being used as a marketing platform by companies using clinical studies to sell access to their putative ‘stem cell treatments’,” Dr. Turner writes.
When just anyone can list a “clinical trial” on the site, even researchers who aren’t qualified to test their products yet or who deliberately blur the definition of “drug,” that makes the site a less useful tool for patients, keeping patients who might benefit from clinical trials out of them.
Source: Consumer Reviews