Bioprocess,Regulatory Affairs,News

Google – The New Pharmaceutical Regulator?

5 years ago By Bryan

Last Friday, Google stated in a press release that it would no longer be accepting advertisements for “speculative and experimental medical treatments”, including most stem cell or gene therapies, after observing unscrupulous companies taking advantage of patients through offers of untested treatment. Hailed by many as a positive move, this could in fact be seen as another example of the internet giant acting as quasi-regulator for the pharma industry where the FDA and other regulators lag behind.

Over the last few years, stem cell clinics and direct-to-consumer gene and cellular therapies have proliferated hugely, promising cures for a range of diseases from macular degeneration to multiple sclerosis. The treatments have been condemned by many in the health field, with allusions made to “modern snake oil” and preying on the hopes of those who have nowhere else to turn to alleviate their conditions. 

In its statement Google noted that it had seen a rise in “bad actors” offering dangerous treatments, and said that such “deceptive treatments” had no place on its platform. The new policy, set out on its website, will prohibit all adverts for treatments which have no “established biomedical or scientific basis”. The ban, in effect from October, will affect all of Google’s ad services, including YouTube adverts and those the company serves to third-party sites. 

Google’s actions against such companies are only slightly behind first steps taken by regulators worldwide. It was not until June 2019 that the FDA won its first lawsuit against Florida-based U.S. Stem Cell, whose treatments had allegedly blinded at least four patients. While the FDA’s court success was heralded as a big win for patient safety and ensuring satisfactory regulation of stem cell companies, the slow response of the regulator meant that US Stem Cell remained active for four years after the first reports of blindness made the news, halting its injections into eyes but continuing to deliver the treatment to those with spinal injuries, Parkinson’s disease and other chronic disorders.

The regulator has struggled with this problem before: oftentimes, its guidelines have been criticised as overly reactive, as in mid-2009 when a number of pharmaceutical companies received written warnings about sponsored links on Google that had been in place since September the previous year. 

It is easy to understand why this difficulty remains: the FDA and other global regulators are complex machines, battling legal systems and often their own regulations, facing court cases that can take years to complete. Google, on the other hand, has free reign to impose within its own jurisdiction whatever policies it feels it needs to enforce. 

Andrew Ittleman, a lawyer representing several stem cell clients, argued that the recent advertisement decision has placed Google in the role of a “quasi regulator”, creating rulings that will damage legitimate companies along with potentially unethical ones. While it is doubtful that too many in the life sciences sector share this particular sentiment, the comment does bring to the fore a point with some merit: that Google, with its vast influence and huge responsibility, is often thrust into a regulatory role that has implications for the whole sector.

This is not the first time Google has acted as arbiter over what should and should not be seen on its platforms: in July this year, Google-owned YouTube moved to reduce misleading claims by certain healthcare companies after the Wall Street Journal covered a report on the proliferation of fake cancer-cure claims spreading on the site. 

Such actions have in cases proved controversial. Google’s handling of claims of homophobic harassment was criticised after it allowed a controversial YouTuber’s videos to stay up, citing that no policies had been violated. 

In the latest case, Google also received some censure by refusing to reveal how it will specifically determine which adverts should be disallowed, leading the American Medical Association (AMA) to speak out on the company’s transparency. AMA president Patrice Harris argued that Google should share “the process they use to vet advertisements and what evidentiary standard they use for determining which treatments are appropriate to advertise.”

Despite these complaints, and warnings that stem cell and gene therapy companies will simply move to other sites or circumvent the rules, it is clear that Google’s actions will have a major impact for many: in 2019, Google is set to earn 36.2% of digital media spend, though growing competitors such as Amazon will restrict this monopoly in future. In the pharmaceutical industry, the giant is just as prevalent, with health queries making up 5% of all Google searches – a rate of 3,150 “health and wellness” searches a second. 

With its autonomous decisions on what may or may not constitute unethical practices in pharmaceutical advertising, and with the heavy repercussions dished out to companies who break one of its rules – with the potential to completely lose a (if not the) major source of exposure and customer outreach available, Google has found itself on the forefront of a potentially grey area of technicalities, both around nomenclature and ethicality. While the company does adhere strictly to national regulations around both company morality and advertisement, companies are generally advised to also pay attention to Google’s own specific guidelines for marketing on the platform – created entirely by Google alone. 

Overall, anything that can be done to extend stricter regulation over dangerous companies should be lauded, as Google’s new efforts have been. But it is a fine line between punishing unethical companies and restricting innovation and growth. For many in the space, cell and gene therapies are the future, promising huge rewards and genuine benefit for many, so long as they are carefully researched and ethically achieved. Hopefully Google’s efforts will promote a better and more cautious use of research to help people rather than hurt them.

Joshua Neil, Editor
Proventa International

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