A few weeks ago, if you’d been scouring the ever-expanding mass of digitized federal paperwork, you might have noticed a contradiction.
On the one hand, the Food and Drug Administration issued a letter stating that what an Arizona distributor was selling as stem cell therapies were “unapproved” and posed “safety concerns.” On the other, a National Institutes of Health database — clinicaltrials.gov — went right on listing the same merchant’s studies, with a link to the company’s website and the word “Recruiting” displayed invitingly in green.
I don’t agree. Read:
Best regards, Kendall
Please explain how it is related with the contents of the article. I do not see the link between your link and the article.
Good point, Dr. Tierney. I have searched clinicaltrials.gov and seen questionable study postings that are incomplete at best. Mr. Boodman’s careful reporting is concerning. This is not a stem cell hit piece. The cited studies were recent news items, providing a specific example where readers can see that the clinical trials database needs safeguards or improvements to make it useful. Now it is borderline useless. There was a recent time when students were taught to never use Wikipedia as a source. It’s much better now because the Foundation saw the problem and continually works on improving Wikipedia. I have had clinical protocols pre-approved by the FDA and an IRB. I had no choice, Dr. Andrew. Maybe other specialties get a pass? There has to be data that indicates that safety has been evaluated (before I am allowed to prove safety), to the best of the reviewer’s ability, and possible risks have been listed or there is no review of the application. It can be a pain but it protects the researcher and study subject. It’s bad for everyone when someone can leapfrog the system of checks and use humans like mice (sorry, mice) or do so-called studies that are Potempkin Villages solely to sell snake oil. People can be unscrupulous and more often just be somewhat mistaken about a study idea or medical treatment. The human condition, when an idea seems so great that a kind of blindness to the problems or risks makes them invisible to the inventor or researcher – there is no malice but perhaps too much enthusiasm. A careful review by a third party is like having a good editor. Checks and balances; a little tiring that this is our lot and sad there will always be someone that sees our desire for something better or for a cure and uses that to swindle us. We need journalists, scientists, MDs, MD JDs, and our partners to keep speaking out and encourage our better selves and temper our not better impulses. A database like clinical trials.gov can be both helpful and dangerous. The article shows that the website needs a serious review. Open flow of information is a great start but, eventually, someone needs to check if the well has been poisoned. At least checking to see if IRB’s are doing their jobs or just collecting money is a valid point. All part of the discussion about truth, trust, and cost in science and medicine.
This appears to be another stem cell hit piece using the same lame fear tropes. Perhaps this author means well, but the simple truth is that the stem cell debate has been had and is over. Stem cell therapy has reached its tipping point and any “controversy” is largely academic. The American people are tired of the old pill-and-surgery and wait-a-decade clinical trial paradigms. Regenerative medicine is different and requires a different approach, as the 21st Century Cures Act makes clear. For those who cling to the old models, progress can understandably seem unfamiliar, chaotic and scary. But unfounded criticisms of stem cell clinics and government agencies hasn’t worked thus far and won’t work going forward. The people and the market have spoken. Countless people have benefited – and continue to benefit – from stem cell therapy. Making it available to and affordable for as many Americans as possible – with the necessary safety measures taken – should be everyone’s top priority.
All clinical trials registered in clinicaltrials.gov must show that they have been approved by an OHRP-certified Institutional Review Board. These companies enrolling patients in uncontrolled trials of stem cell injections have not had their therapy approved by the FDA, so no IRB should approve of those studies. Assuming that these companies paid commercial IRBs to approve their studies, then those IRBs should have their OHRP certification revoked, putting them out of business. That would prevent future IRB approvals of such non-FDA approved interventions, and that should put a stop to their fraudulent registration in clinicaltrials.gov as a marketing ploy would stop.
Seriously, Dr. TIerney? Surely you must realize that the very reason most clinical trials occur is IN ORDER FOR THEIR SPONSORS TO ATTEMPT TO SECURE FDA APPROVAL by proving safety, efficacy etc. Under your proposed scheme, there would be essentially no clinical trials, and thus no further therapy development or innovation. Except possibly new uses for already approved interventions. Do you honestly believe that every intervention that could possibly be developed therapeutically, already has been introduced and approved?
Dr. Tierney – excellent point. One easy improvement would be to require disclosing on the site which Institutional Review Board approved the study, to allow for greater accountability. Better than that, there should be three large questions at the top of the page of every interventional trial: “Do subjects have to pay to participate?” “Has an IND application been filed with the FDA?” “Was the study approved by an Institutional Review Board? Provide the name of the Institutional Review Board, with approval number, and approval start/end dates”. If the answer is “Yes” to the first question or “No” to the other two, show the answers in big red letters with a warning. (Some studies are exempt from needing an IND- would have to provide room to explain that, and some international trials do not have to file an IND- they can simply disclose that, but that should not happen in the U.S.) P.S. Dr. Andrew’s comment is not accurate- IRB approval is required BEFORE the first study for a therapy is started on humans.
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