Background: Hospitals, clinics begin treating patients with controversial stem cell therapies
The announcement comes as hospitals and clinics throughout the United States have begun treating various conditions with stem cell therapies, despite a lack of clear evidence the treatments are effective.
FDA in December 2018 sent 45 warning letters to manufacturers of stem-cell-related products, and the agency in May 2018 filed lawsuits against US Stem Cell Clinic of Sunrise, Florida, and California Stem Cell Treatment Center to stop the clinics from marketing unapproved stem-cell treatments. In addition, FDA in April sent warning letters to at least 20 companies the agency believed were offering unapproved stem-cell treatments and products to consumers, and a federal judge in June ruled in favor of FDA regulating clinics offering unproven stem-cell procedures.
However, FDA has created a few exceptions for certain stem cell treatments, meaning doctors can provide those treatments as long as they meet certain criteria. Still, some experts have questioned whether hospitals should be bringing in money off these procedures, given the limited evidence they actually work. Many researchers have argued the unproven treatments put patients at risk and, in a few cases, the treatments have led to serious patient injuries. Some medical associations and scientists have gone so far as to liken the untested procedures to a modern-day snake oil, saying companies offering the treatments are preying on patients who are seriously ill.
Google announces new policy banning ads for unproven treatments
According to Andrew Ittleman, a Miami lawyer who represents stem cell clinics, Google over the past two years has been declining to accept advertisements from stem cell companies on a case-by-case basis.
But Adrienne Biddings, Google's policy adviser, in a blog post published Friday announced that Google now is instituting a complete ban on ads for treatments with "no established biomedical or scientific basis," as well as treatments that are rooted in scientific evidence and preliminary clinical experience "but currently have insufficient formal clinical testing."
Biddings wrote that the ban, which is scheduled to take effect in October, will apply to all of Google's ad services, including advertisements placed on YouTube and third-party websites.
Biddings wrote that Google will enforce the ban using a combination of machine learning and human review. A Google spokesperson added that Google's policy team formulated the new approach by conducting a literature review of the field and working with stem cell experts, according to the Post.
Biddings wrote that the new policy stems from the company noticing "a rise in bad actors attempting to take advantage of individuals by offering untested, deceptive treatments." She added, "These treatments can lead to dangerous health outcomes and we feel they have no place on our platforms."
Biddings wrote that Google will continue to accept ads for clinical trials approved by the federal government, adding that the company "believe[s] that monitored, regulated clinical trials are the most reliable way to test and prove important medical advances."
Paul Knoepfler, a stem cell biologist at the University of California-Davis and a critic of for-profit stem cell clinics, said Google's new policy is a big deal because many patients who have been injured from unproven stem cell procedures were recruited using Google ads. "A number of us have pushed for this kind of policy over the years, so this news is a welcome surprise," he said.
Deepak Srivastava—president of the International Society for Stem Cell Research, a leading group of scientists who provided Google with advice on its new policy—said, "Google's new policy banning advertising for speculative medicines is a much-needed and welcome step to curb the marketing of unscrupulous medical products. The premature marketing and commercialization of unproven stem cell products threatens public health, the confidence in biomedical research, and undermines the development of legitimate new therapies."
However, some stem cell clinics and industry representatives, which argue their treatments might help patients with limited options, criticized Google's new policy.
Ittleman said Google's new policy will indiscriminately target both "good" companies, which are seeking to safely treat patients in accordance with FDA's evolving regulations, and "bad actors." He said the policy "puts Google in the position of being a quasi regulator, taking on quite a significant amount of jurisdiction."
The American Medical Association (AMA) called on Google to make public how it determines which ads to ban. "The AMA is pleased to see that Google appreciates the seriousness of this issue, and we urge them to make public the process they use to vet advertisements and what evidentiary standard they use for determining which treatments are appropriate to advertise," AMA President Patrice Harris said. She added that AMA "believes it is critical to distinguish between treatments that have been validated by appropriate scientific study, those that are promising, and those that are without foundation."
Other observers said they do not expect Google's new policy will have a financial impact on stem cell clinics because they'll still be able to generate business.
For instance, a former marketing head for a Florida stem cell company, who spoke on the condition of anonymity, told the Washington Post, "This kind of ad ban hits hard because most companies rely on Google for a large share of their quality sales leads. But there are plenty of other channels you can switch to—Facebook, Bing, Yahoo. These kinds of businesses are pretty savvy and have had to adapt a lot already. Many have previously been kicked off Google already. You learn to pivot and be resourceful" (Wan/McGinley, Washington Post, 9/6; Wan/McGinley, Washington Post, 6/4; Graham, CNBC, 9/6; Google release, 9/6; Google's health care and medicine advertising policies, accessed 9/9).