The Florida Attorney General announced a lawsuit against Internet pharmacy DirectDietPills.com for engaging in a “bait and switch” scheme. (We put DirectDietPills.com on our unapproved list some time ago.)

According to WMBB News 13, the website’s fine print specified that if the prescription form wasn’t sent in within three days by the doctor, the website would send an herbal product instead, but bill for the prescription drug. Customers were basically ordering the prescription drug, paying prescription drug prices, and then getting an herbal product in the mail. Presumably, sometimes the patient would take the herbal product thinking it was the actual prescription drug.

Publicly available information explains why we put DirectDietPills.com on our unapproved list months ago. The Ohio State Board of Pharmacy found that the website was shipping drugs into Ohio, and then provided false information about being licensed in that state. That information has been publicly available since February 2006.

Furthermore, we were troubled by the website’s lack of transparency and full disclosure. For example:

• The AG’s press release indicates that DirectDietPills.com is in Florida, and is owned by Direct Pharmacy, Inc., which is owned by Steven and Rachael McMurtrey.
• There is no pharmacist in Florida with the last name of McMurtrey.
• The website, which is still active, doesn’t disclose the dispensing pharmacy on its website, or even if there is one.
• The domain is registered anonymously.

This is a good example of what LegitScript looks at in determining whether an Internet pharmacy is legitimate. We insist on transparency and, absent extenuating circumstances, won’t approve an online pharmacy with an anonymous domain registration. The publicly available information from the Ohio State Board of Pharmacy clearly indicated that the business was involved in deceiving its own customers. Finally, we insist that there be a link between control of the website and a bona fide pharmacy or pharmacist.

LegitScript’s tech team just added a pretty cool little feature to our website: an indication of whether a particular online pharmacy is online or offline. Although it’s not particularly meaningful if looking at just one website (after all, you could just go to that website to see if it’s online or not), it’s a really great tool if you’re monitoring hundreds or thousands of websites within an affiliate network, or (as LegitScript does) the entire rogue Internet pharmacy world.

But aren’t all Internet pharmacies always online? Actually, we’ve found that it depends upon the affiliate network in question. As you might expect, most online pharmacies that meet LegitScript standards are online nearly all of the time. But some rogue Internet pharmacy networks, like the Xin Net fake Canadian Pharmacy network, purchase thousands of websites and, to avoid being shut down, rotate among thousands of websites, only keeping a handful up at a time. (Sneaky!)

So, that sort of information helps us better understand “rogue” affiliate network business practices, and also keep our own database current.

We’re going to be adding in some similar toolkits over the next couple of months that will help us in developing “macro”-market level data about both the legitimate online pharmacy market and the rogue Internet pharmacy world.

The Ryan Haight Online Pharmacy Consumer Protection Act just passed the House and will hit the Senate (very likely a pro forma vote) before going to the President’s desk for his signature.

For those hoping for a veto: No chance. President Bush will sign the bill. Top officials at the DEA, ONDCP and FDA started meeting internally and discussing the need for some sort of a clearer definition about what constitutes a “valid prescription” way back in 2004. (Some felt more strongly about it than others, but that’s a whole ‘nother story.) Bush made it the topic of his radio address in early March of this year, calling for the bill’s passage.

Like most legislation, it’s an imperfect solution to a complicated problem. The bill has some good provisions, and overall, LegitScript welcomes the increased clarity regarding the definition of “valid prescription” as well as tougher sanctions for Schedule III, IV and V offenses. The latter provision will likely encourage Assistant US Attorneys, who are often reluctant to take Schedule IV cases due to the difficulty of getting “real time,” to file more cases involving Ambien, Xanax, Valium and Phentermine, which are (by definition) “drugs of abuse” and a real problem on the Internet these days. (Again, a subject of a future blog.)

Want evidence that prescriptions based solely on an online consultation aren’t legal? Look to the New York Dept. of Health’s decision last week revoking the medical license of Dr. Joyce Wong Buckley.

What did (former) Dr. Buckley do? It would appear that writing prescriptions for an Internet pharmacy’s customers without ever physically examining them can get you charged with 78 counts of misconduct, including gross negligence, failure to comply with state laws and regulations, and failing to maintain patient records. Even if the prescription drugs aren’t controlled substances. (The complaint didn’t indicate which Internet pharmacy or affiliate network was involved.)

There are two things about the complaint and findings that we find especially interesting:

1. Dr. Buckley made $2.00 for each prescription she wrote. We’ve heard of cases where the doctor was making $3.00 or $4.00 per prescription. But knowing how doctors value their time, it’s hard to believe that doctors in cases like this take a good ten or fifteen minutes to review each patient’s history, call them, et cetera. If they did, they would only make $10 – $20 an hour. The incentive in cases like this is to simply race through the prescriptions, signing one every few seconds.
2. None of the drugs that Dr. Buckley prescribed were controlled substances. There were only four drugs listed that Dr. Buckley wrote prescriptions for: Soma (a muscle relaxant), Tramadol (a pain killer), Fioricet (for migrane headaches) and Levitra (for erectile dysfunction). (A curious question: why do so many Internet pharmacies focus on those first three drugs, Soma, Tramadol and Fioricet?)

Additionally, one of the charges, as noted above, was “failure to comply with state laws and regulations.” It will be interesting to see if there are other charges, perhaps by the State Attorney General, that may be pending. Stay tuned.

We just added 425 rogue Internet pharmacies that are all affiliates of Affiliate Pharmacy Network, a rogue Internet pharmacy network. Why do we feel comfortable labeling those websites as rogue Internet pharmacies? It’s pretty straightforward:

• The websites offer prescription drugs without requiring any prescription at all. There’s not even a pretense at an “online consultation.”
• The drugs come from overseas.
• We called the company. They told us that they get the drugs from “four fulfillment centers” around the world, most in India and Asia. True? Who knows. But we know that they are violating US law by coming in from outside of the country without some sort of FDA approved-process and inspections in place.

Two of the network’s best-known affiliates are easy.md and medrx-one.com. Troublingly, all websites appear to allow the use of Visa for payment.

Every year, the federal government releases a report, the National Survey on Drug Use and Health, that estimates the number of drug abusers in the United States, and which drugs are most commonly abused. The report, which is the single most important document used to determine our nation’s priorities in the War on Drugs, was released again this month.

How much of that is due to the Internet? Some well-respected blogs like Internet Pharmacy Law and Internet Drug Law have already noted that the Internet is not thought to be the main driver in Prescription Drug Abuse. Rather, it is friends and family: those who share unneeded or unused medications.

If we get more granular, however, the government’s study doesn’t make sense: it concludes that just 0.5% of prescription drug abuse is due to the Internet. Common sense, as well as hard data, tells us that this can’t be true. (Side note: in every conversation I’ve had with government officials at ONDCP, the FDA, the DEA, and SAMHSA about this, every single person, without exception, agrees that this number is flawed. This blog explains why.)

Beginning in 2005, survey respondents who admitted abusing prescription drugs were asked how they obtained them. Roughly two-thirds of survey respondents indicated that they obtained the prescription drugs from “friends or family.” And Internet pharmacies? A paltry 0.8%, 0.7%, and most recently, 0.5%, respectively over the last three years.

So just 35,000 Americans – 0.5% of the seven million prescription drug abusers in the US – are sustaining the multi-billion dollar rogue online pharmacy market? Something doesn’t add up. A closer look at the survey explains why it is flawed, misunderstands common online pharmacy business models, and dramatically understates the role of the Internet in modern-day drug abuse.

First, what drugs are considered in the survey? Controlled substances are, as well as some drugs of abuse that are not (yet?) controlled, like Soma, Tramadol and Fioricet. But what about Viagra, Cialis, Levitra, Nexium, and so forth? These drugs are not evaluated, because they are not considered “drugs of abuse.” Therefore, a huge chunk of the online pharmacy is not represented in the study. It’s also important to remember that the study only attempts to measure the harm caused by prescription drug abuse, and doesn’t touch counterfeiting.

Second, what is the common practice these days for many online pharmacies that do not meet LegitScript’s standards? These sites offer “prescriptions” based on an online questionnaire in lieu of being physically examined by a doctor. As we’ve discussed before, the legitimacy of this practice is questionable. When applied to controlled substances and drugs of abuse, there’s no question that in some cases, these online consultation websites have been an enabler of prescription drug abuse. But in only 1 out of 200 cases?

Unlikely. Here’s the problem. Such websites assure customers that they are being given a “valid prescription.” Yet the government’s drug abuse survey directs participants to answer questions about prescription drug abuse only “if the drug was not prescribed for you.” This results in respondents who purchased their drugs online (most of whom were informed by the online pharmacy that they were being given a valid prescription) simply skipping the questions about prescription drug abuse, making the government’s official finding about how much of a role the Internet plays in prescription drug abuse artificially low. In other words, the government’s study doesn’t define what “prescription” means, adding to the confusion.

A real-world look at hard facts shows how the federal government’s own numbers don’t add up. Consider this: the study estimates that 7 million people were “current” (past-month) prescription drug abusers in 2006. If just 0.5% of those (35,000) people sourced their drugs from the Internet, how do we explain the DEA’s congressional testimony that in 2006, “thirty-four known or suspected rogue Internet pharmacies dispensed 98,566,711 dosage units of hydrocodone (generic Vicodin)”? Even making the impossible assumption that all 35,000 people ordered hydrocodone and no other prescription pills, it would mean that each person ordered more than 2,800 pills ⎯ nearly eight pills a day, from only those 34 websites.

And look to the Department of Justice’s convictions just last month related to BuyMeds.com, a rogue Internet pharmacy based in Florida. Although the criminal actions took place in 2003 – 2004, from that operation alone, DOJ indicated seizures of nearly $12 million in “rogue” prescription drug money from activity over a 14-month period. Do the math: LegitScript has documented over 10,000 “rogue” online pharmacies. Even if we assume that only 1% (about 100) of the 10,000 online pharmacies are similarly profitable, each of the 0.5% of prescription drug abusers getting drugs from the Internet would each have to spend nearly $35,000 a year on prescription drugs. Again: possible, but not likely.

This flaw in the government’s data has been a valuable tool for opponents of the Online Pharmacy Consumer Protection Act a bill that would crack down on “rogue” Internet pharmacies and clarify that prescriptions written solely on the basis of an online questionnaire are not lawful. If government data shows that the Internet is just half of one percent of the problem, argue the bill’s opponents, why pass a new law? As of this writing, the bill is gradually making its way through the US House of Representatives, but its future is uncertain.

Government data is helpful when it’s reliable. Here, the data have people inside the government scratching their heads: how can we be shutting down all of these rogue pharmacy websites, seizing millions of dollars, but our own studies tell us that the Internet plays almost no role in prescription drug abuse? The answer is easy: the study isn’t asking the right questions the right way, and doesn’t take into account that “online consultation” websites tell the customer that they are being given a valid prescription, all the while enabling drug abuse (in some cases). While the Internet may not be the primary source of prescription drug abuse, it’s not reasonable, based on other objective facts, to believe that the government’s study got it right. As such, the government should re-evaluate the questions in its own survey, and make sure that the data upon which drug policy is based incorporates a real-world understanding of how online pharmacies actually do business.

The House Energy and Commerce committee is moving forward on the HR 6353, otherwise known as the Ryan Haight Online Pharmacy Consumer Protection Act, this very morning. The inside scoop: it’s likely to pass and be on the President’s desk by the end of the month, or early next.

LegitScript supports the legislation. However, we’re concerned that the bill only applies to controlled substances. In short, the bill explicitly defines a “valid prescription” to require a prior in-person examination by a physician.

That’s great. However, 90% (or more) of shady Internet pharmacies aren’t selling controlled substances like hydrocodone or Xanax. Rather, they are selling non-controlled substances: Soma, Tramadol, Fioricet, Viagra, Lipitor, and the like. Passage of this bill will almost certainly give weight to the argument that for those drugs, Congress explicitly meant to not require a prior in-person examination.

That’s not an argument that LegitScript buys, for reasons we’ll blog about later. But it’s going to be an unintended and negative consequence of an otherwise good bill.

We uploaded fifty new “rogue” online pharmacies this morning. These websites, which include winners like official-canadian.com, mypills.org and sevendayspharmacy.com are all part of the same international criminal network.

These websites are low-hanging fruit: if you’ve received spam for Viagra, Cialis, Levitra, or any number of other drugs recently from an Internet pharmacy, chances are that it came from a website affiliated with this network. They call themselves “Canadian Pharmacy”, but here’s what we know about them:

• The are most likely operating out of China and/or Russia.
• They are linked to organized crime.
• They are spammers.
• If you order drugs like Viagra, Lipitor or Soma from this network, you may or may not receive anything in return.
• If you do order drugs from these websites, you have a good chance of getting counterfeit drugs.

What else do we know about these websites? About half of them are registered to EstDomains.com, which has recently been the subject of several news stories about its “sordid history.” The others are at a mix of registrars, although the InterCosmos Media Group (doing business as DirectNIC) has an unusually large chunk of the websites as well.

Here’s some news: the FDA has blocked imports of some generic prescription drugs from Ranbaxy Laboratories in India, the world’s largest generic manufacturer. According to the Boston Globe:

FDA inspections earlier this year found violations that could lead to contamination, allergic reactions, and other problems, and the company hasn’t taken proper steps to correct them, said Deborah Autor, director of FDA’s compliance office.

Here’s what we think is really going on: as LegitScript has discovered, online pharmacies are selling Ranbaxy products and the FDA is trying to get to the bottom of why.

Let’s back up. LegitScript has performed test buys from rogue Internet pharmacies. Some of the drugs arrived with Ranbaxy packaging and labels, from India, without a valid prescription. And numerous rogue online pharmacies claim to sell Ranbaxy’s generic drugs.

There are only two explanations: either the drugs are counterfeit, or the real Ranbaxy products are leaving the legitimate, FDA-approved chain of commerce somehow.

It’s right for the FDA to try and figure out why this is happening. After all, just because the drugs are in Ranbaxy packaging doesn’t mean that they aren’t counterfeit. But it could mean that Ranbaxy chemists are trying to make an extra buck by producing products, either real or adulterated, out the back door.

Bloggers on pro-steroid websites have been jubilant over the last 48 hours, since the dismissal of a New York indictment against Signature Pharmacy owners for sales of anabolic steroids, allegedly without a valid prescription, was announced. Signature had been accused of, among other things, having doctors write sham prescriptions for steroids based only on filling out an online form.

So online consultations without an in-person visit are okay now, right? Not so fast.

First, nine defendants (about half of them) have already pleaded guilty in this case. Attorneys don’t generally let their clients plead guilty without conceding that the government has a solid case. Period.

Second, keep in mind that this case was brought under New York State law, which is admittedly a bit more murky on this topic than the law of other states. (New York State law will be the topic of a separate blog.) One state, one judge, a few defendants. Not wise to draw any meaningful conclusions from this, especially about Federal law or the possible success of such indictments in other states.

Third, the judge didn’t dismiss the case because there wasn’t one. Rather, the judge dismissed the case because the DA’s office gave incomplete and insufficient instructions to the Grand Jury, and because of how many indictments, superseding indictments, and so forth, had emerged. (Side note: this is unsurprising as Signature Pharmacy is alleged to have constructed a fairly elaborate national scheme, so it’s natural that prosecutors would have tried to update indictments as they discovered additional information, possibly from defendants who gave them that information after pleading guilty.) This is basically a dismissal on a technicality, not a “not guilty” finding after full adjudication. (Keep in mind, of course, that the defendants are innocent until and unless proven guilty beyond a reasonable doubt.)

Fourth, let’s not forget the overall issue here: Operation Which Doctor is said to have stopped millions of dollars in illegal anabolic steroid sales; some of these allegedly are linked to the death of pro-wrestler Chris Benoit. If the allegations were correct, this was a massive drug-dealing operation.

The media is portraying this as is there wasn’t ever a case. Wrong conclusion. In fact, given the number of guilty pleas so far, the right conclusion is that Operation Which Doctor has been successful, and the guilty pleas of the defendants do indicate that something very wrong was going on with the overall operation.

The American Pain Foundation named LegitScript.com website of the month. (This was actually in their August issue…we’re a bit late in blogging about it.)

LegitScript’s President, John Horton, also wrote an article entitled Keeping the Internet Safe for Pain Medication Access for the American Pain Foundation. The article identifies some things to look for (and watch out for!) in choosing an online pharmacy.

The American Pain Foundation is a nonprofit that aims to improve the quality of life of people with chronic pain. That’s a mission that LegitScript gladly supports.

Here’s a question: what does the FDA’s recent listing of prescription drugs with potential safety risks mean for Internet pharmacies?

At first glance, not much. The current list of twenty prescription drugs doesn’t indicate the reasons that the FDA believes that the drugs warrant special scrutiny. And it doesn’t appear, overtly at least, to relate to Internet pharmacies in particular.

Actually, it’s relevant. Here’s LegitScript’s take.

First, note this quote from CNN.com:

“My message to patients is this: Don’t stop taking your medicine,” said Dr. Janet Woodcock, who heads the FDA’s Center for Drug Evaluation and Research. “If your doctor has prescribed a drug that appears on this list, you should continue taking it unless your doctor advises you differently.”

Dr. Woodcock appears to be saying: we, the FDA, have some concerns about these prescription drugs. But you’ve got a relationship with your doctor, who presumably knows your medical condition; he or she should make the decision about whether these drugs are safe for you to take.

So what does this mean for websites that sell these prescription drugs without requiring a prescription, or websites that employ a physician to write a prescription based on an online questionnaire, without physically examining the patient?

Although Dr. Woodcock’s comments aren’t directly on point, they reinforce the reason that certain drugs are declared “prescription” drugs while others are “over the counter”: by definition, the former require some degree of medical supervision. It would seem logical that patients who are taking these particular prescription drugs should insist upon having a physician examine them in person, rather than simply filling out a form over the Internet.

Not dispositive. But it would seem to be another argument in favor of requiring an in-person examination.

Evaluating online pharmacies is serious business, but occasionally we run across something worth having a laugh over.

Online Time Travel Pharmacy promises that their pills “will help you time travel.” The pills are (will be?) shipped from India in the year 2395, but will arrive in the present. They do this, in part, because some of the prescription drugs they sell generic versions of are currently under a patent; by 2395, those patents will have expired, making shipment of generic versions lawful in the United States in the late 24th century.

In indicating that customers must fill out an “online questionnaire” and need not see a physician in person (a practice that is a bar to LegitScript approval), Online Time Travel Pharmacy promises that this is in accordance with FDA regulations in the year 4358.

Funny though it is, we laugh at parodies because they retain a modicum of truth: online pharmacies that ship drugs from outside of the country, or that fill a prescription based solely on an online questionnaire, are often promising more than they can deliver in terms of safety, quality and legality. That’s why LegitScript thinks those practices are no laughing matter, and encourages consumers to verify online pharmacy safety and legitimacy at LegitScript.com.

Earlier this week, we blogged about Orlando Birbragher who was convicted (along with several others) in Federal court for his operation of rogue Internet pharmacy BuyMeds.com. We determined that despite the fact that he is facing three to four years in prison, his website, BuyMeds.com, is registered to somebody with a similar name ⎯ Andres Birbragher ⎯ until 2014.

Our concern: Orlando Birbragher was using the website as a tool for drug dealing. The same tool shouldn’t be waiting for him when he gets out of prison, or remain in his de facto control while he is in prison.

A reasonable conclusion is that Andres Birbragher is Orlando Birbragher’s son, and that Orlando Birbragher can either remain in de facto control of the website, or sell it for a profit, during and/or after his release from prison. Here’s why:

• The University of Miami website and the New York Social Diary suggest that Orlando Birbragher is married to Alexis Birbragher.
• The indictment has Orlando in Miami; Alexis Birbragher is listed as a real estate agent also in Dade County, Florida.
• Andres Birbragher’s address is listed, according to GoDaddy, as 8002 Ponce de Leon Rd., Miami, Florida.
• According to HouseFront.com, that house is owned by somebody named “Orlando Birgragher.” (Note the misspelling.)
• The house is currently being offered for sale for (cough) $4,000,000 by Alexis Birbragher.

Actually, it gets better.

Andres Birbragher has several felony convictions, including a drug conviction. A criminal records search reveals convictions for Armed Burglary, Carrying a Concealed Weapon, Marijuana Possession, Assault, and two counts of Aggravated Battery with a Dangerous Weapon.

Here’s the problem with all of this. As a practical matter, BuyMeds.com is still in Birbragher’s control, and will be there waiting for him when he’s released from prison. Meanwhile, it’s in the control of another convicted felon. Birbragher will be able to do one of two things with the domain name: control it, perhaps illicitly, or profit from its sale.

The most reasonable course of action would be for GoDaddy, as a matter of policy, to terminate the Birbraghers’ ownership of the website.

We sent out a reminder this morning about LegitScript’s feature that allows Internet users to report a rogue online pharmacy. So far, LegitScript’s visitors have helped push us past the 10,000 mark. (Yes, that means that we’ve documented more than 10,000 rogue online pharmacies!)

How many rogue pharmacy websites exist in total? Nobody knows, but we’re sticking with our estimate of 25,000 or so. That said, the number is always changing. And, most of these websites are part of rogue Internet pharmacy networks. In other words, hundreds of websites actually link back to just one prescription drug supplier, even though all of the websites look identical, so there aren’t actually 25,000 separate suppliers.

Dr. Bryan Liang of the Pharmaceutical Security Institute recently blogged about some criteria for helping identify whether an online pharmacy is legitimate or not. (Of course, the first thing to do is to look for either the VIPPS Seal of Approval or the LegitScript Seal of Approval.) Dr. Liang recommended the following as red flags:

• The site does not have a physical address or telephone number is listed.

• The site does not have a licensed pharmacist available to answer questions.

• There is no way to talk to a person if problems arise regarding suspect contraband or counterfeit medication.

• The site does not ask for the name, address, or phone number of your current doctor.

• The site does not require that a valid prescription issued by a physician be provided before filling the order.

• The site offers to sell drugs without a prescription or only requires a buyer to fill out a questionnaire to receive drugs.

• The site does not accept any insurance and requires that all payments be made with a credit card.

• The site requires that you waive some rights before sending the drugs.

• The site “advises” consumers about drug importation laws and why it is “permissible” to obtain prescription drugs from foreign countries via the Internet.

• The site encourages buyers to have the drugs sent to post office boxes.

Here’s a conundrum: what to do with a rogue Internet pharmacy website after the registrant has been criminally convicted.

On August 4, 2008, according to the US Department of Justice, Orlando Birbragher was convicted of running a rogue Internet pharmacy, BuyMeds.com. He pled guilty to several crimes, including money laundering and conspiracy to illegally distribute controlled substances.

He’s probably going to prison, but GoDaddy still has him as the registrant for the website. Until 2014, by which time he’ll likely be out of prison. (He faces a maximum of ten years, but probably will serve just a year or two at the most.)

Let’s be specific. The website is down, but is still registered to one “Andres Birbragher.” I think that we can assume that “Andres Birbragher” is either an alias for Orlando Birbragher, or a family member that allows him to retain virtual control.

What should be done with the website? On the one hand, it doesn’t make sense for GoDaddy to turn around and sell it to another rogue Internet pharmacy operator. But should Birbragher be allowed to keep it? (Of course not.) Should he be allowed to sell it for profit? (After all, it probably has some value on the domain names market.) Again, of course not: the website was a instrument of criminality. Birbragher, who just had to cough up $3.78 million in forfeited drug money, shouldn’t be allowed to resell it and pocket the cash.

The question: what will GoDaddy do with this website registration? Stay tuned…