The FDA held a summit with representatives of corporate Internet giants today to discuss further collaboration to stanch online opioid sales.
Among those in attendance were representatives of Google, Facebook, Microsoft, Oath (formerly Yahoo), Twitter, Mastercard, and AliBaba (the mammoth Chinese e-commerce company).
We are seeing an “evolution” in the opioid epidemic, FDA Commissioner Scott Gottlieb said Wednesday afternoon, which is “increasingly fueled by illicit substances purchased online or on the street.”
Gottlieb and other FDA speakers repeatedly emphasized their concern that as lawful opioid prescribing subsides—it’s been dropping since about 2010—those seeking opioids will turn to illicit sources on the web. (A recent study in The BMJ found that when the DEA placed tighter strictures on the sale of hydrocodone in 2014, illicit trading in prescription opioids through online “cryptomarkets” increased.)
The greatest concern, of course, is that such buyers will be sold illicit fentanyl—wittingly or unwittingly, since it is sometimes pressed into counterfeit pills, which appear to be Vicodin or oxycodone. More than half of opioid overdose deaths are now associated with fentanyl use. (Fentanyl is 30-50 times more powerful than heroin.)
“Some efforts are being done quietly,” Gottlieb said, “so we don’t tip off bad actors.”
In addition to Gottlieb, presentations were made by Janet Woodcock, the director of the Center for Drug Evaluation and Research; and Don Ashley, the CDER’s Office of Compliance. Although the FDA speeches were publicly webcast, all those by others present were kept closed, in part, Gottlieb said, because of “security sensitivities.”
Also present were representatives of industry trade groups like the Internet Association, the Center for Safe Internet Pharmacies, and the Alliance for Safe Online Pharmacies.
CSIP is an educational group, funded by Internet companies like Google (a unit of Alphabet) and Paypal, while ASOP is a lobbying organization, composed largely of pharmaceutical companies.
The FDA has focused on a 2015 study by Carnegie Mellon University, which found that online illict drug sales grew from $15-17 million in 2012 to $150-180 million in 2015.
CSIP this week issued a 47-page report analyzing opioid sales on the dark web (also known as the darknet). After reviewing the 12 most popular “cryptomarkets” there, their researchers found more than 100,000 drug listings, of which 8.1 percent were opioids. Cannabis and MDMA (ecstasy) were the most popular drugs for sale—accounting for 25.8 percent and 17 percent of the listings, respectively.
The dark web is a portion of the Internet accessible only by a so-called Tor browser, which, through encryption, protects the identity of the user and website purveyor. CSIP’s research suggests that most purported vendors of opioids on the surface web—the familiar web that you’re on now—are engaged in identity theft or credit card fraud, and do not really deliver pharmaceuticals. Vendors on the darknet, by contrast—like the notorious Dream Market—are quite real. (Dream Market accounted for 56.1 percent of all drug listings found by the CSIP study, and 50.2 percent of all the opioid listings.)
Early on at the summit, the FDA’s Ashley commended Google, Bing, and Facebook for steps they are already taking.
Google “deindexes”—i.e., makes invisible to searches—sites that are the subject of FDA warning letters.
Bing attaches popup warnings to such sites.
Facebook, as was announced just last week, now redirects users looking to purchase opioids to a SAMHSA national helpline link.
“I understand some [additional] efforts are being done quietly,” Gottlieb added during his presentation, “so we don’t tip off bad actors.”
Gottlieb said that the FDA had doubled the number of FDA special agents at ports of entry, including international mail facilities. Whereas these agents had been involved in 115 arrests in 2017, they have already effected 90 this year.
The FDA shares responsibility for interdiction of illicit drugs entering through the mails with the Customs and Border Protection officials, postal inspectors, and the DEA.
Opioids illegally ordered online are typically delivered by international mail or delivery services. Most illicit fentanyl is produced in labs in China, according to the DEA; some is mailed directly into the U.S., while some is transshipped through other countries, including Mexico.
“We’ll have more takedowns to announce pretty soon,” he said.
Though he did not mention it, the Department of Justice announced 35 arrests yesterday as part of “the first nationwide undercover action to target vendors of illicit goods on the darknet.” The joint takedown—which also involved the Secret Service, DEA, Homeland Security, and the US Postal Inspection Service—333 bottles of liquid synthetic opioids, 100,000 tramadol pills, 100 grams of fentanyl, 24 kilograms of Xanax, other drugs, guns, and $23.6 million dollars in cash and Bitcoin.