The illegal drug market is worth over $300 billion a year in the US and up to $36 trillion globally. Much of it can now be found online in the “dark web”, “dark net” or the “deep web”. Naturally, this is now a source of contention for federal law enforcement and the FDA will have to play a game of “catch-up” in the coming years in order to regulate this new uncharted territory. Back when I wrote this series of blogs I focused my Dark Web story on Silk Road as the epitome of illegal drug markets, which was shut down in 2013. Since then, many other underground online drug market places have emerged and have been shut down also (AlphaBay and Hansa are just two recent examples).
What is the Dark web?
99 percent of the internet is the dark web, none of which is indexed by major search engines such as Google and Yahoo. Users can join the Tor network, or use the Deep Web Harvester to access data online without the possibility of government or commercial surveillance. Websites on the dark web do not rely on cookies to track users so people can access sites and set up websites anonymously. It is a very easy process to install the Tor browser and enter into the dark web.
This can be a good thing and a bad thing. For lawyers, journalists and researchers, the dark web can provide a wealth of metadata about virtually any subject or person, all of which can be searched with a guarantee of freedom and privacy. Lawyers gathering information for evidence in litigation cases can find a host of resources leading to unpublished court cases and documents that could help them win legal battles. On the other hand, criminals can use the dark web for a vast variety of illegal activities, including the marketing of weapons and drugs. Worse still, payments for all items are done through Bitcoins, an online peer-to-peer currency which is mostly untraceable.
In 2013 the FBI and the Department of Justice shut down Silk Road, the biggest online distributor of illegal drugs. The mastermind behind the website, Ross Ulbricht (also known as Dread Pirate Roberts) has now been sentenced to life in prison. As soon as the original Silk Road was taken off, Silk Road 2.0 and other sites emerged to take its place and since then there has been a huge increase in online underground drug markets. For example, Evolution Market Place became a major drug distributor after Silk Road and gained notoriety when it suddenly vanished in March this year, taking away $15 million in Bitcoin payments from customers.
Agora was the biggest underground drug retail website to emerge after Silk Road (at its peak they owned 82% of that market). Digital Citizens’ Alliance, which monitored illicit online markets, reported that as of April 2015, up to 4 major dark web drug-market websites, including Agora, Nucleus, Black Bank Bitcone and Alphabay, listed over 43,000 illegal drugs. All of these market place websites have since been shut down but new ones have emerged to replace the inexorable demand by consumers for illegal drugs. A list of top 40 illegal market places can be found here today.
Supply and demand
The continued growth of underground online drug markets, even after the shutdown of the original Silk Road, is suggestive of an inexorable demand for unregulated drugs. Of all the items being sold on the dark web, drugs occupy the largest proportion.
While some users of these websites are indeed addicts looking for a faster way to acquire risky medication away from street dealers, many online buyers simply cannot afford medical insurance, or are genuine patients trying to buy therapeutic drugs at a hugely discounted price. Online dealers often sell drugs that originate from the same pharmaceutical companies as those found in an ordinary pharmacy or hospital but at prices that are not competitive on the legal market by industry standards. There are also terminally ill patients who cannot gain access to the drugs they want before FDA approval. Often such patients desperately seek drugs that do not qualify for treatment INDs, expedited development designations or drugs that have been approved in other countries that have yet to gain approval in the US. What is most remarkable about the system of buying drugs on the dark web is that customers can leave feedback anonymously about the seller and rate them out of 5. According to The Telegraph in the UK, “Over the course of three months, around 120,000 pieces of feedback were left on Silk Road 2.0… and on average, “buyers left a score of 4.85.” This leads one to believe that most people who bought drugs on the website were actually very happy with the results and that they would continue to use such services. The power of choosing drug products lies completely in the hands of the buyer rather than the drug manufacturer, the regulatory agency or the government. Of course if the consumer were to experience adverse reactions brought along by fraudulent, ineffective drugs they would not be protected by US laws.
How does this affect drug patents and FDA regulation?
A lot of potential exists for criminals to tap into the illegal drug market, selling drugs without NDA approval. It would not be surprising if most of the drugs being sold on the Tor network have already violated patent protection laws in the US. A slew of legislation concerning cyber information and privacy has been passed in the last few years under the jurisdiction of the Federal Trade Commission. Some of these include the Fair Credit Reporting Act and Protecting Cyber Networks Act, which provide a process for the pubic to voluntarily share cyber data that could be threatening to national security. However, I have searched high and low on the (visible!) web but have not come across any Federal statutes or FDA regulations for guidances regarding underground online drug markets. In order to reach a balance between the prohibition of illegal narcotics and the availability of affordable, lifesaving, unapproved prescription drugs for terminally ill patients, Congress should grant FDA some authority over the regulation of dark web drug markets. There are several ways this can be done. For example, just as the Protecting Cyber Networks Act enables collaboration between the Departments of Justice, Commerce, Treasury, Energy and the Office of the Director of National Intelligence, a new act could be legislated to enable collaboration between the FDA and the aforementioned government agencies, increasing vigilance on cyber drug regulation. Another way would be to increase the online surveillance resources at the FDA specifically to target fraudulent drugs on the dark web. In light of the ever-changing landscape of the modern internet as a global market place, the FDA will have to work more closely with organizations such as the Center for Safe Internet Pharmacies and the Digital Citizens’ Alliance to ensure patient safety and public education are held to the highest standards.
What can you do?
The arena for regulating underground drug markets on the internet is ripe for new legislation. Find out the latest news and public education materials from the Center for Safe Internet Pharmacies and Alliance for Safe Pharmacies about ordering drugs safely online. You can monitor and report suspicious activity to the Federal Trade Commission in underground drug markets by joining the Tor network — it is free.
References:
The Dark Web:
http://www.economist.com/blogs/graphicdetail/2015/05/daily-chart-13
http://www.makeuseof.com/tag/journey-into-the-hidden-web-a-guide-for-new-researchers/
https://www.cryptocoinsnews.com/unstoppable-evolution-dark-net/
Video Documentary:
https://www.youtube.com/watch?v=osln0IWh__Q
Buyer and Seller feedback on the Dark Web:
http://www.telegraph.co.uk/technology/internet/11466413/What-dark-net-drug-buyers-say-about-their-dealers.html
Center for Safe Internet Pharmacies:
http://www.safemedsonline.org/2014/07/rogue-online-drug-marketplaces-pose-dangers-consumers/
Cybersecurity legislation:
http://www.crainsdetroit.com/article/20150618/BLOG109/150619855/cybersecurity-legislation-requires-consolidation
Originally published at shenlinlab.com.
