Laurie McGinley and William Wan of the Washington Post broke the story this morning that Google has a new biomedical ad policy that may really shake things up for stem cell clinics. Google announced the new policy on its blog that will restrict advertisements for unproven stem cell clinics, cellular and gene therapies. This is great news.
Google Ads for stem cell clinics have definitely driven hundreds if not thousands of customers to unproven stem cell clinics. It’s very likely that many of the patients who have ended up in the hospital due to bad outcomes from clinic injections first went to those firms because of Google ads. These ads and certain particularly risky clinics also are a real threat to the legitimate stem cell and gene therapy fields.
From the Google post:
“We regularly review and revise our advertising policies. Today, we’re announcing a new Healthcare and medicines policy to prohibit advertising for unproven or experimental medical techniques such as most stem cell therapy, cellular (non-stem) therapy, and gene therapy. This new policy will prohibit ads selling treatments that have no established biomedical or scientific basis. The new policy also includes treatments that are rooted in basic scientific findings and preliminary clinical experience, but currently have insufficient formal clinical testing to justify widespread clinical use.”
The FDA likely helped spark this new policy, if nothing else indirectly via their increased action and blunt public statements against what they (and Google, probably not coincidentally) call “bad actors” in this area. Also perhaps not coincidentally, the FDA came out with a major announcement/warning on stem cells a few days ago. You can see a screenshot from the FDA video in the warning that I’ve included here.
There’s a potential caveat though about the new policy, which will go into effect next month.
I wonder if the policy will extend to how Google ranks the websites of the firms selling the unproven biomedical offerings. For instance, even if Google won’t run ads for unproven stem cell clinics, if the clinics’ websites still rank highly in Google results for a search like “stem cells autism”, Google is still in essence facilitating the risky clinics getting customers. At the same time, I wonder how well Google will be able to fine tune the policy so as to not impede appropriate stem cell and gene therapy online material. Some clinics and supporters of certain clinics are going to pushback, although I’m not sure there’s much they can do. From the Post story:
“Some industry representatives criticized Google’s new ad policy on Friday. The ban on ads will unfairly devastate “good” companies along with “bad actors” without discriminating which ones are trying to treat patients safely and follow evolving FDA regulations, said Andrew Ittleman, a Miami lawyer who represents several stem cell clinics.”
It’s worth noting that some stem cell clinics, while selling unproven offerings, are nonetheless FDA compliant. There’s also a wide spectrum of clinics out there and some not following FDA regs are definitely in a high-risk category unto themselves. The Post story rightly mentioned that some clinics will likely adapt their marketing and ads to try to bypass the policy.
Overall, I see the new policy by Google as a positive step and support them taking it. Perhaps some mainstream media outlets will follow suit and also adopt policies whereby they do not run these risky biomedical ads.
I see this as a good thing. If you read my World View article in Nature- I said that my hope was that the FDA approved therapies will outcompete the charlatans….eventually. Right now there are no approved applications beyond HSC transplants for cancers, so there is no competition. But there will be…very soon, I hope.
Google, or any other private company like Facebook, censoring the internet for the government sets a dangerous precedent that will end up having negative, unintended consequences. Having Google interpret and enforce federal regulations is also not good. If a business is doing something illegal, that should be enforced by the FTC, FDA, and/or any other relevant federal agency such as the FBI. This goes for everything, not just stem cell clinics.
I do wonder how Google is going to implement their new policy in the real world and how “accurate” for lack of a better word their actions will be. How many non-stem cell clinic ads will be affected by mistake?
If they extend the policy to clinic website ranking that could have additional impact, but at the same time how many “good citizen” websites will be dinged by mistake?
I am against Google (or Facebook, etc) putting its thumb on the scale of organic search results – for any subject – period. The notion that so-called “bad” ideas should be erased from the Internet, presents an existential threat to the free flow of information. Who gets to decide which information, companies, and people should be deplatformed? I think a day of regulatory reckoning is coming for these companies if they continue down this path. Fight “bad” ideas with better ones. That’s the way forward in my opinion.
But surely in the broader scheme of things some types of online ads should be (and already are) blocked like for, for instance, illegal products or services, right? Where do you draw the line? At least some stem cell clinic activities actually are now clearly illegal, even if many other unproven offerings aren’t technically illegal. And of course some are fully FDA compliant.
I’m with Bill Jones on this one. Paul, the more important issue is not where to draw the line on which ads should be restricted. The more important issue is who and how they are restricted. And the answer is not by Google and not by Google’s choice of methods. This would be another abuse of Google’s information grip on us all. Next they will be deciding to decide who gets to speak on social media…wait, they are already doing that!
There are many other less dangerous approaches to limiting the detrimental effects of misleading stem cell treatment ads. As Jean suggests, the one that will certainly work is providing patients with effective alternatives. However, there is a significant human arbitrage in effect now. Maybe there are 30,000 or so opportunities for treatments in FDA-authorized clinical trials each year worldwide, compared to as many as $250,000 patients seeking uncertain treatments in private stem cell clinics in the U.S. alone (my crude estimates that I was asking Paul about in an earlier comment post). In both of these treatment settings, patients are motivated by their understanding that the treatments are NOT established to NOT be effective. Desperation and hope overwhelm the uncertainties, and even safety risks, in both settings.
Now, nearly 10 years ago, the ISSCR issued Stem Cell Clinical Translation Principles for when and how it is ethically permissible to proceed with “medical innovation” to administer stem cell treatments that have not been approved by FDA-authorized clinical trials. What we need is the leadership of many, many accredited medical research centers to begin providing such medical innovation treatments, according to the ISSCR principles, to give patients the alternative to “bad actor” private stem cell clinics that is currently missing. According to the ISSCR principles, medical innovation treatments also occur with essential documentation that is needed to advance to FDA-authorized clinical trials when warranted by initial positive treatment outcomes. Also very important, documented medical innovations can establish when treatments are NOT effective, which is no small thing to know in the current free for all with all sorts of things being tried.
Of course, if such a stem cell medical innovation movement could be achieved, Google might end up censoring participating medical research centers’ information and study recruitment ads, too!
Unfortunately, the 2017 FDA guidelines were not properly enforced. The discretionary three year period was a bad idea. The state medical boards, Federal Trade Commission and FBI have not done enough to enforce fraud by “bad actors”. This allowed manufacturers and hundreds of healthcare providers to advertise Section 361 products as if they were a “stem cell” therapy. And this, combined with the fact that the current healthcare system does not adequately meet the needs of many patients, is why we have the current challenge.
Now we are forced to rely on Google to take action. And who at Google is going to make the determination if a specific treatment option is “proven”? What evidence will they use? Although the number of prospective, randomized clinical trials on the treatment of orthopedic conditions with PRP, bone marrow aspirate or micro-fragmented adipose tissue are limited, there is growing evidence for their safety and efficacy in specific indications.
The way forward?
Physicians – educate and treat your patients based their specific needs, the scientific evidence and FDA guidelines.
Scientists – focus on completing well designed clinical trials.
State and Federal regulators – enforce the law.
No, it´s good. If you want to access unproven drugs for cash you now have to download Tor and go to the deep web, where you´ll find dubious stem cell clinics sandwiched between assassins for hire and underage pornography.
Using it right now Bill – in fact you couldn´t be more wrong as I use it by default. I open a circuit with the Orbot app and a global VPN and then browse with Orfox or Firefox or any other browser, including Google if that´s your thing. Maybe it´s use that have never used Tor?
Actually, my thinking was that users don’t need Tor to use a search engine other than Google that isn’t suppressing results. However, I suppose if all search engines did it, then I see your point. I have used Tor from time to time but I don’t find it necessary for the most part. I don’t think Google should be acting as a quasi regulator though.
Seems straightforward. If you have an approved FDA IND and clinical trial (not just IRB), then Google should allow clinical trial recruitment. If you do not, then you are not approved to treat patients. If clinicaltrial.gov had same rule that you must state if you have FDA approval for your trial, it would end much of the BS. Common sense, but then I am just a veterinarian.