Rogue Internet pharmacies, unsurprisingly, do not particularly appreciate LegitScript’s efforts to call them out on what they are doing. The latest: rogue Internet pharmacy network 121Doc is trying to silence LegitScript.

We stand by our classification of the 121Doc network as rogue. Additionally, one of the points we continue to make is: if an Internet pharmacy is willing to be untruthful in its representations to us (or to its customers), it is not unlikely that they are misrepresenting the source or quality of the drugs they sell. Read 121Doc’s email to us from earlier today closely:

Sirs,

Unless you immediately cease and desist all such activities and libelous references against our site within 48 hrs, we will have no option but to institute proceedings against you without further notice…

Let’s break this analysis down.

First, 121Doc’s email claims that they don’t ship to the United States, and are thus not violating our laws, which prohibit shipping prescription drugs directly to patients from outside of the United States in nearly all cases for safety reasons. Just today, LegitScript submitted a test order for Viagra, putting in a fake US address, and without having a prior prescription. Moreover, we used a non-existent credit card. Those are three things that would make the transaction illegal.

Second, their FAQs talk about how long shipment takes to the United States.

Third, when you arrive at the purchase page, the default shipping address is the United States. Pretty clearly, 121Doc’s statement to us the “(o)rders are not processed for customers located outside the UK or EU registered states” is inaccurate: they are offering to ship prescription drug to the United States in violation of our federal laws.

Fourth, it is not legal to dispense a prescription drug without a valid prescription. Simply filling out a pre-filled in form for the drugs that 121Doc sells, without ever been examined in person by the physician (much less one that isn’t even located or licensed in the United States), is not the basis for a valid, lawful prescription. We did not have a prescription when we submitted the prescription drug order.

Fifth, if 121Doc network Internet pharmacies are actually using UK-licensed physicians and accredited Internet pharmacies in the United Kingdom to dispense prescription drugs, we hereby issue a public invitation for 121Doc to disclose the identities of those pharmacies, and those physicians, to LegitScript, as well as to the authorities in the United Kingdom and other countries in Europe. It is perfectly reasonable to ask: if 121Doc is actually using licensed pharmacies and physicians in the UK, then what’s to hide?

All of this is consistent with our past investigations of 121Doc. Previously, we have similarly conducted test orders from websites within their network, and engaged in test chats with their “live chat” assistants. Previously, in those chats, they indicated that they were willing to ship to the United States. (Today, apparently expecting our chat inquiry and recognizing our IP address, they claimed in a chat they would not ship to the United States, but then we were immediately able to complete a test order for Viagra without a prescription and with a US-based address.)

LegitScript identifies, monitors and exposes Internet pharmacies that act contrary to the laws of where they do business, and/or engage in unethical or unsafe pharmacy practices. 121Doc is a rogue Internet pharmacy network because it doesn’t require a valid prescription as per the laws of most US states, and it sends US residents drugs that are not FDA-approved. It’s a very clear cut situation. However, we have a standing offer for 121Doc and all rogue Internet pharmacies: we will remove rogue classifications if and when the websites, and the pharmacy practices, comply with the laws and pharmacy practice standards of the countries where the website offers to dispense prescription drugs. We encourage 121Doc to begin this process.

However, if an Internet pharmacy is willing to skirt the laws where it does business, and willing to engage in deceptive behavior with LegitScript, Internet users who choose to fill their prescriptions online have every right to be concerned that the Internet pharmacy will cut corners with their safety as well.

Columbia University Graduate School students in journalism just published an article worth reading in the Huffington Post. It’s about rogue online pharmacies using YouTube to reach customers and improve SEO. (LegitScript was quoted several times in the article.)

The notion that rogue online pharmacies would post videos on YouTube isn’t surprising; after all, YouTube/Google Video tends to improve SEO, which is of key importance to rogue online pharmacies. The more interesting discussion touches on companies that profit from displaying ads for, or facilitating the displaying of ads for, rogue online pharmacies. Although unpaid search results for rogue online pharmacies are probably protected by the Communications Decency Act, this doesn’t apply to paid ads (also called “sponsored search results”).

One of the approved advertisers that the article discusses is WholesaleVIPClub.com. If you simply visit that domain, it doesn’t appear to have any relationship to online pharmacies. Instead, you have to visit a subdomain, such as cheapmeds.wholesalevipclub.com (or, in the past, soma.wholesalevipclub.com, oxycodone.wholesalevipclub.com, et cetera).

LegitScript’s quarrel with wholevipclub.com isn’t the inclusion of drugs like soma, Xanax, oxycodone and others in the domain name. That isn’t illegal (although it is pretty shady in most cases). And, an Internet pharmacy that simply lists Oxycodone as one of its products isn’t, by virtue of that fact alone, violating the law. (It has to comply with the Ryan Haight Act and other laws, of course.) Rather, we looked at what cheapmeds.wholesalevipclub.com was doing and found that it violated several of our standards in several respects, including referring paid members to websites that violate the Food, Drug and Cosmetic Act.

But the other interesting, and to us disturbing, thing is that it gets Internet users to pay a fee for information that is available for free elsewhere: it is one of at least a dozen websites, mostly run by individuals in Florida, Texas, and overseas, that get you to sign up with a monthly fee, and then just gives you a list of websites that they copied from another online pharmacy verification service that provides that information for free on its own website. It isn’t illegal, but LegitScript’s view on this is that if information is available for free elsewhere, charging a fee for it isn’t looking out for the best interests of the patient. The fact that nearly all of these “referral” websites are registered anonymously at the very least raises an important question: what do the owners of websites like cheapmeds.wholesalevipclub.com have to hide? (Perhaps they don’t want outraged customers to contact them directly once they find out that they paid for information that is available for free elsewhere.)

The U.S. Department of Justice announced that a Virginia doctor, Torino Jennings of Mechanicsville, has been charged for violation of the (federal) Food, Drug and Cosmetic Act, and for tax evasion. At the heart of the indictment was Dr. Jennings alleged filling of prescriptions for Soma (and presumably other drugs), a “legend drug” (non-controlled substance) without ever seeing the patient in person.

DOJ alleges that:

…between 2004 and 2007, (Dr. Jennings) issued between 50,000 and 100,000 prescriptions over the Internet for Soma, and other drugs, to individuals whom he had never performed a physical examination on and had never met…based on forms completed by individuals for online pharmacies. (And) the online pharmacies paid JENNINGS between $5.00 and $7.00 for each prescription he wrote.

There are a couple of interesting and important things about this.

1. The Ryan Haight Online Pharmacy Consumer Protection Act explicitly made the filling of a controlled substance prescription without ever having seen a patient in person a violation of the Controlled Substances Act. However, there has been substantially more debate about whether existing law prohibits filling a prescription for a non-controlled substance in the same manner.
2. It is interesting that DOJ is basing its prosecution not merely on violation of the FDCA, but also apparently tax evasion.
3. Historically, we’ve seen the average amount that a physician receives per prescription (for controlled substances) based on online consultations in the $2 – $4 range, although certainly sometimes much higher.

So what’s really going on here? Our analysis: rogue online pharmacy operators have shifted (not entirely, but meaningfully) to selling non-controlled substances like Soma, tramadol, fioricet, and erectile dysfunction drugs, based on the (we believe) false premise that no in-person examination is usually required for those drugs, and that they could escape enforcement or regulatory oversight. But Soma, tramadol and other drugs are in the small category of abusable (addictive) drugs that are nevertheless non-controlled substances. It was only a matter of time until federal and state law enforcement, now that the Ryan Haight Act is fully implemented and enforceable, were going to turn their attention to non-controlled substances.

What about the involvement of the IRS and the tax evasion charges? It would probably be a mistake to conclude that if a physician simply reports income obtained in this way, that they will avoid scrutiny. Rather, it’s largely a method that law enforcement uses to go after illicitly obtained revenue, and an additional hammer that the Department of Justice can use, whether at trial or in plea negotiations.

All of that said, this is an important case to watch. If it fails, it’s going to embolden those who argue that Soma, tramadol, Viagra, Fioricet, Propecia and other drugs can be sold over the Internet by online pharmacies that don’t require you to see the physician (or an associate of the physician) in person. But in that case, a likely result will be a movement to enact federal legislation that expands the Ryan Haight Act requirements to non-controlled substances, to clarify the law on that point. On the other hand, if the prosecution succeeds, it will embolden law enforcement who will see these cases as winnable and a source of asset recovery, and will set some degree of precedent. (However, it will also embolden those who argue that no additional law, or clarification of existing law, is needed.)

LegitScript does not approve any pharmacy website that facilitates the sale or filling of any prescription drug based solely on an online consultation.

The National Association of Boards of Pharmacy earlier this week released a position paper on Internet pharmacies. As the independent, international, and impartial association that assists pharmacy boards in developing, implementing, and enforcing uniform standards for the purpose of protecting the public health, the NABP is in a strong, and influential position to the continuing national conversation on this issue.

Among the concerns noted by the NABP:

• The continuing presence of rogue Internet drug outlets in the search engines’ sponsored search results.

• The inaccuracy and unverifiability of much WhoIs data (meaning, the contact information that a website registrant submits when registering a website), especially for rogue Internet drug outlets.

• The continued willingness of credit card companies to act as the merchant processor for rogue Internet drug outlets.

• The solicitation of domestic pharmacies and pharmacists by rogue Internet drug outlet networks to fill prescription drug orders without requiring a prescription.

A recent study has found that General Practitioners (GPs)in the United Kingdom reported treating 1 in 4 patients for side effects from medications ordered online. The side effects ranged from allergic reactions to ill-effects of counterfeit medications. Says Telegraph.co.uk:

The findings prompted warnings from GPs, regulators and pharmacists that patients should be careful about buying drugs online, highlighting the prevalence of fake medication.

The study focused on practitioners in the UK, which leads us to wonder if the findings would be similar here in the US. In any case, the study speaks to the need for caution in confirming that Internet pharmacies meet baseline criteria for legality and safety.

In July of last year, LegitScript and spam fighter KnujOn sent out letters to eight US-based registrars requesting that they terminate or suspend websites they were sponsoring that offered to sell steroids, a Schedule III controlled substance, without a prescription, from overseas (both illegal and dangerous). Eventually, six of the eight registrars terminated all of the sites. The sole exceptions were Parava Networks, supposedly in Texas, and eNom.

LegitScript and KnujOn sent Parava a letter to the address it had provided to the Internet Corporation on Assigned Names and Numbers (ICANN). Not only did Parava not respond and not terminate the illegal websites, the letter bounced back to us, with the US postal service indicating that there is “no such address.”

Well. In other words, this was a domain name registrar that was sponsoring rogue Internet pharmacies, couldn’t be reached, and had apparently provided ICANN with false registration about its location. Meanwhile, it continued to register rogue Internet pharmacy domains, including several affiliated with (probable-) Russian-crime-sponsored 33drugs.com. No response to our continued notifications.

KnujOn spearheaded the complaint process to ICANN. Due in significant parts to KnujOn’s efforts, and as a direct consequence of Parava’s refusal to adhere to ICANN requirements following our requests, ICANN has now informed Parava that it is deaccrediting Parava as a registrar, and shutting Parava down.

This is an important development in the fight against rogue Internet pharmacies. It’s important to note that the provisions used to terminate Parava were not directly related to its knowing sponsoring of illegal Internet pharmacies, but rather its lack of an accurate address and other factors. But this is similar to ICANN’s termination of rogue Internet pharmacy sponsor Estdomains a few months ago, which was also de-accredited for ostensibly different reasons than its sponsorship of criminal websites. As a practical matter, registrars that knowingly sponsor criminal websites and fail to adhere to ICANN requirements may be susceptible to increased attention, including arguments that they are failing to adhere their contractual obligations under ICANN agreements.

Following the passage of the Ryan Haight Online Consumer Protection Act in October 2008, the DEA has issued interim regulations. These interim regulations go into effect on April 13, 2009; the public comment period on the interim regulations ends on June 5, 2009. After that, the permanent regulations will be enacted.

Additionally, any pharmacist who operates an online pharmacy within the definition of the new law must, starting on April 13, 2009, update their DEA registration to obtain permission to operate as an online pharmacy.

The 30+ page interim regulations were just released yesterday (April 6, 2009) and LegitScript staff are poring through them now. We’ll be working with the online pharmacies we’ve approved over the next few weeks to ensure that all online pharmacies are up-to-speed and in compliance with both the law and the regulations.

We just crunched some interesting data about rogue Internet pharmacies and domain name registrars.

As some of our readers know, domain name registrars (like GoDaddy, eNom, NetworkSolutions, etc.) have the ability to shut down websites for illegal behavior, and are contractually obligated to make sure that the websites they sponsor aren’t engaged in illegal activity.

LegitScript began notifying registrars about a few rogue Internet pharmacies in the middle of 2008, starting with about 150 illegal anabolic sites. Of the eight registrars we notified about these sites, six of the eight ended up shutting the sites down (most were registered to GoDaddy). Since then, we have had rogue Internet pharmacies terminated by a variety of other registrars including Joker.com, FastDomain, NetworkSolutions and several others.

But we wanted to conduct a more in-depth analysis, so we conducted a sort of pilot project where we focused (primarily, but not exclusively) on notifying one registrar in particular: Directi, a leading registrar located in India.

In conducting this pilot project, our primary question wasn’t just about how many illegal websites we could get shut down. Rather, we were interested in understanding: If we terminate a whole bunch of sites sponsored by one registrar, how will the rogue Internet pharmacies respond?

The response has been interesting, and telling.

Aout six months ago, roughly 10% of rogue Internet pharmacies in our database were sponsored by Directi. Today, that number is down to about 0.5%, about one out of every 200, despite Directi’s status as the world’s 10th largest registrar. (Keep in mind that LegitScript maintains the world’s largest public database of non-spam rogue Internet pharmacies, with about 36,000 domains on our list, so it’s a pretty good representative sample.)

What’s also fascinating is that of the websites Directi shut down at our request, 75% of them have remained offline. That’s pretty good: a traditional concern among law enforcement about terminating sites is that if one registrar shuts down a site, it will just pop back up elsewhere. Our efforts have proven that that is not true.

But the most interesting factoid is how the rogue Internet pharmacies responded. Of the 25% that are back online, more than 1/3 went to eNom. It’s true that eNom is the second-largest registrar in the world, so statistically, we expected that some rogue sites would naturally choose eNom. However, the trend was much stronger than we anticipated.

These data indicate that rogue Internet pharmacy operators know that they can’t consider Directi a safe haven. Based on that, we consider our pilot project a success, and look forward to expanding it to other registrars.

KGET in Bakersfield, California ran an interesting story this morning about a woman who was killed in a automobile crash. Her family blames her addiction to Soma, which they say she was getting online:

(The woman’s daughter) says her mom started taking a muscle relaxer called Soma after she hurt her back skiing. But 44-yr-old Laura Clearwater’s family says she quickly became addicted. They say the drug was originally prescribed by a doctor, but then Clearwater started ordering the drugs from an online pharmacy and every week pills arrived at their doorstep.

The article goes on to say that the family thinks that Ms. Clearwater’s addiction to Soma may have been a contributing cause to the accident:

Her family doesn’t know the exact cause of the crash but says they want to warn others about the power of prescription drugs and the deadly addiction that stole their mother’s life. The corner’s office says it has not determined if drugs or alcohol played a role in the crash.

It’s important to acknowledge, of course, what we don’t know from the article: whether Ms. Clearwater was, in fact, under the influence of Soma (which is an addictive drug) at the time of the accident, which online pharmacy was used, whether the online pharmacy is domestic or foreign, which affiliate pharmacy network was involved, and whether it was sending the drugs on the basis of a valid prescription or not.

Yet, we can point out some important facts and draw some safe conclusions. First, Soma is addictive, and along with tramadol (Ultram) and Fioricet, is among the most drugs that are most widely marketed online without a valid prescription being required. Why? It’s because those drugs are a few in a small but dangerous category: recognized as addictive on the prescribing labels, they are nevertheless not federally controlled substances, and thus do not fall under the direct purview of the US Drug Enforcement Administration.

Second, although we don’t know if Ms. Clearwater was under the influence of Soma at the time of the accident, there’s no question that some people fighting drug addictions drive under the influence of those drugs, and that driving under the influence of drugs (including prescription drugs that alter judgment or reaction time) can be just as dangerous as driving under the influence of alcohol. Soma, a muscle relaxant, definitely falls under this category.

Third, the article refers to an important illicit practice commonly used by rogue online pharmacies:

…Clearwater started ordering the drugs from an online pharmacy and every week pills arrived at their doorstep.

We’re seeing this more and more: a very aggressive “automatic refill” practice that doesn’t take into account whether the patient has a genuine need for the drugs, but operates as nothing more than a form of online drug pushing (with automatic credit card debits, of course!). Legitimate Internet pharmacies refill prescriptions as well, so this point isn’t dispositive, but it suggests that a closer look at the online pharmacy’s refill policies is warranted.

Finally, articles like these raise an important question about domain name registrars. A domain name registrar like GoDaddy or eNom doesn’t, in our view, have any potential legal liability for websites like these if they don’t know about the content. After all, registrars can’t be expected to monitor the content of every website they sponsor.

However, domain name registrars have the ability to terminate or suspend websites engaged in illicit activities that they know about. They regularly do this for spam websites, for example.

What if the registrar had been notified by LegitScript that the online pharmacy it was sponsoring was selling these addictive prescription drugs without requiring a valid prescription, yet declined to terminate or suspend the website? Although there are plenty of “causation” issues to be resolved (whether the drugs played a contributing role in the crash), if a registrar knew about the illicit online pharmacy, declined to terminate or suspend the website and continued to profit from the website’s registration, and the online pharmacy subsequently sold the drugs without a valid prescription…

You get the point.

LegitScript is pleased to announce approval of rxproblemsolvers.com, the Internet presence of The Compounding Shoppe, a licensed pharmacy in Alabama.

As its name suggests, The Compounding Shoppe focuses on the compounding of prescription medicines. The pharmacy has been in the family for three generations, and is accredited by the Pharmacy Compounding Accreditation Board. The Pharmacist-in-Charge is also a member and a full fellow of the International Academy of Compounding Pharmacists.

LegitScript has verified that rxproblemsolvers.com meets LegitScript’s standards for online pharmacy website legality and safety.

The Compounding Shoppe specializes in pharmacy compounding, or the custom-making of medicines based on a prescription order from their doctor. Each pharmacist is an expert in hormone replacement therapy and specializes in pain management focused on the unique needs of each patient. The pharmacy also focuses on wellness consultations, in which the pharmacy’s naturopathic pharmacist helps people develop rational therapy plans to return to wellness.

LegitScript is pleased to recognize rxproblemsolvers.com as a legitimate pharmacy website that meets LegitScript’s standards, which are recognized by the National Association of Boards of Pharmacy.