New Campaign Against Bogus Online Pharmacies

By Pat Anson, Editor

The U.S. Food and Drug Administration has launched yet another campaign against illegal online pharmacies, sending warning letters to the operators of 53 websites that they must stop marketing oxycodone, tramadol and other opioid medications.

"This illegal online marketing of unapproved opioids is contributing to the nation’s opioid crisis,” said FDA Commissioner Scott Gottlieb, MD.  “Opioids bought online may be counterfeit and could contain other dangerous substances. Consumers who use these products take significant risk with their lives.”

Gottlieb said the FDA would take additional steps in coming months to stop the online sale of opioids and their shipment through the mail. The agency also plans to hold a summit June 27 with internet stakeholders, researchers and advocacy groups to find new ways to work collaboratively to address the problem.

Last September, the FDA sent similar warning letters to over 500 online pharmacies as part of an international operation called Pangea X. Interpol said it seized over $51 million in illicit and counterfeit medications as a result of the investigation. Over 400 people were arrested worldwide and 3,584 websites shut down.

The problem with these law enforcement efforts is that many of the bogus pharmacies are quickly back online under different names and website addresses.  

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Some of websites being targeted in the latest FDA crackdown operate brazenly, offering opioids and other controlled substances without a prescription.

“One advantage of buying medication through our website is that it’s cheap and exciting. Sometimes, what happens is that the drug can only be bought with a prescription, and getting prescription is not that simple,” one operator claims. “(We provide) the solution to this. We don’t require any prescription or proof of recommendation. If you need any sort of medication, just go to our website, log in and place the order. After the payment is made, the order is finalized and shipped to your place.”

Another website claims “you won’t need a written prescription from a doctor as we have doctors within our team who will write your prescription free of cost.”

Online Pain Pharma then displays images of four smiling “doctors” with specialties in radiology, emergency care, radiology and rheumatology. The names appear fictitious and the pictures are stock photo images that can be purchased from a website that sells images of “Smiling Medical People With Stethoscopes.”

image from onlinepainpharma.com

image from onlinepainpharma.com

Dr. Anna Mariya may be a radiologist for Online Pain Pharma, but on a pediatrician's website she’s an orthopedic specialist named Dr. Bagavativarasyar.  

The FDA warning letters were sent to nine online pharmacy operators, most of which have multiple websites. They were given 10 working days to respond.

"The public needs to know that no one is authorized to sell or distribute opioids via the internet in the U.S., with or without a prescription," said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. "Drug dealers and rogue website operators are using the internet to fuel the opioid crisis, heartlessly targeting millions of Americans struggling with opioid use disorder.”

According to one estimate, as many as 35,000 online pharmacies are in operation worldwide. About half are selling counterfeit painkillers and other fake medications. About 20 illegal online pharmacies are launched every day.

Counterfeit Pill Problem ‘Getting Worse by the Day’

By Pat Anson, Editor

Counterfeit painkillers and fake medications made with illicit fentanyl have killed Americans in at least 22 states, according to a new report by the Partnership for Safe Medicines (PSM) a coalition of pharmacy and healthcare organizations. Counterfeit pills laced with fentanyl have now been found from coast to coast in 43 states.

“This updated report shows that the illegally-imported fentanyl problem is getting worse by the day,” said Dr. Marvin Shepherd, chairman of the PSM Board.

Fentanyl is 100 times more potent than morphine. It is prescribed legally for severe pain, but illicit fentanyl has become a scourge on the black market, where it is typically mixed with heroin or cocaine. Rogue manufacturers also press it into counterfeit prescription pills such as Vicodin, Percocet and Xanax.

Unsuspecting buyers – including pain sufferers looking for relief -- often have no idea what they’re getting.

According to a recent CDC report, drug deaths involving fentanyl (19,413) surpassed overdoses linked to prescription opioids (17,087) in 2016.

COUNTERFEIT PERCOCET

COUNTERFEIT PERCOCET

“The annual count of overdose deaths from prescription opioids has remained constant since 2011, but deaths from fentanyl poisoning have spiked since then. As fentanyl-laced pills mimicking legitimate medication have flooded the illicit drugs supply, prescription drug users have been poisoned by the counterfeits,” the PSM report found. 

“The tally of deaths because of counterfeit pills made with fentanyl is probably undercounted because lab protocols lagged behind this shift and weren’t testing for fentanyl.”

The pills are difficult to trace, as Minnesota prosecutors admitted last week when they announced that no criminal charges would be filed in the accidental overdose death of Prince. The music icon died two years ago after taking counterfeit painkillers that were “an exact imitation” of Vicodin.

“Prince thought he was taking Vicodin and not fentanyl,” said Carver County Attorney Mark Metz, adding that dozens of counterfeit pills were found in Prince’s home, many of them stored in aspirin bottles.

Investigators were unable to determine how or where Prince obtained the fake pills, but they are readily available online for anyone who cares to look. According to one report, there are as many as 35,000 online pharmacies operating worldwide. Many do not require a prescription and are selling counterfeit medications. Their customers include some pain patients who are no longer able to obtain opioids legally from doctors and are looking for other sources.

‘Criminals Are Pretty Smart’

“They’re looking, maybe innocuously, for medicine online. They’re searching for ‘fentanyl online’ or ‘Percocet buy.’  Not because they want to buy medicine on the Internet, but rather they just want to find medicine,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies, an industry supported non-profit.

“The criminals are pretty smart. They know that there’s a market out there and they know they can offer these medicines to patients for good reasons, bad reasons or otherwise that are looking for those medicines. And they are going to get duped because they are very likely buying from a website that is selling it illegally.”

The National Association of Boards of Pharmacy recently evaluated 100 websites selling medications and found that almost all were operating illegally and selling drugs without a prescription. Over half (54%) were selling controlled substances and 40% were offering drugs that are frequently counterfeited with fentanyl.

The marketing and selling of counterfeit medicine goes beyond just online pharmacies. Drug dealers are increasingly using Facebook, Twitter and message boards to reach customers. PNN recently received this sales pitch from one dealer:

"We have pharmaceutical drugs for your health illness especially for Chronic Pain, Anxiety, Depression, Panic Disorder. ADHD, Xanax Bars, Narcolepsy pills, Antidepressants, Antipsychotics, Benzodiazepines, Narcotics, Opiates, weight loss/fat burner. We do overnight secure shipping."

Warning unsuspecting buyers about the easy availability of these drugs poses a dilemma for law enforcement and policy makers.

“We have ethical tension around all of this. On the one hand, we certainly don’t want to be educating people that you can buy controlled substances or prescription drugs on the Internet without a prescription, counterfeit or otherwise. That’s just dangerous. But we also don’t want to be in a position of not warning them or not making a policy response to the fact that this currently exists,” Baney told PNN.

It is relatively easy to tell the difference between a legitimate online pharmacy and an illegal one. The URL’s for websites that end with “.Pharmacy” (not .com or .net) are certified by the National Association of Boards of Pharmacy and are in compliance with laws and practice standards. You can also visit buysaferx.pharmacy to verify whether a website is legitimate.

Feds Target Doctors and Pharmacies in New Crackdown

By Pat Anson, Editor

Over the next few weeks, the Drug Enforcement Administration will step up investigations of pharmacies and doctors found to be dispensing or prescribing suspicious amounts of opioid pain medication.

The so-called “surge” -- announced by Attorney General Jeff Sessions – is the latest in a series of steps the Justice Department has taken to combat the opioid crisis.

“Over the next 45 days, DEA will surge Special Agents, Diversion Investigators, and Intelligence Research Specialists to focus on pharmacies and prescribers who are dispensing unusual or disproportionate amounts of drugs,” Sessions said during a Tuesday speech to law enforcement officials in Louisville, KY.

“DEA collects some 80 million transaction reports every year from manufacturers and distributors of prescription drugs.  These reports contain information like distribution figures and inventory.  DEA will aggregate these numbers to find patterns, trends, statistical outliers -- and put them into targeting packages,” Sessions said.

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"That will help us make more arrests, secure more convictions -- and ultimately help us reduce the number of prescription drugs available for Americans to get addicted to or overdose from these dangerous drugs.”

But that kind of data mining of opioid prescriptions -- without examining the full context of who the medications were prescribed for or why – can be problematic and misleading.

For example, the DEA last year raided the offices of Dr. Forest Tennant, a prominent California pain physician, as well as two pharmacies regularly used by his patients. Tennant only treats intractable pain patients, many from out-of-state, and often prescribes high doses of opioids and other prescription drugs  because of their chronically poor health. Some of his patients are in palliative care and near death.

Those important facts were omitted or ignored by DEA investigators, who alleged in a search warrant that Tennant had “very suspicious prescribing patterns” and was part of a drug trafficking organization.

“It’s not like he’s just giving out high doses of medication and running a pill mill, like they said. That to me was the most asinine statement in that whole search warrant,” said Riley Holder, a disabled pharmacist with intractable pain who is one of Tennant’s patients.

Tennant has denied any wrongdoing and has not been charged with a crime.

Last August, Sessions ordered the formation of a new data analysis team, the Opioid Fraud and Abuse Detection Unit, to focus solely on opioid-related health care fraud.  He also assigned a dozen prosecutors to “hot spots” around the country where opioid addiction is common. In November, Sessions ordered all 94 U.S. Attorneys to designate an opioid coordinator to help spearhead anti-opioid strategies in their district.

FBI to Target Online Pharmacies

Sessions this week also announced the formation of a new FBI investigative team, called the Joint Criminal Opioid Darknet Enforcement (J-CODE) unit, which will focus on shutting down illegal online pharmacies. Dozens of FBI agents and intelligence analysts are being assigned to J-CODE.  

“Criminals think that they are safe on the darknet, but they are in for a rude awakening. We have already infiltrated their networks, and we are determined to bring them to justice,” Sessions said. “The J-CODE team will help us continue to shut down the online marketplaces that drug traffickers use and ultimately that will help us reduce addiction and overdoses across the nation.”

As PNN has reported, the online pharmacy business is booming. As many as 35,000 online pharmacies are operating worldwide, and over 90 percent are not in compliance with federal and state laws.  Many do not require a prescription, and about half are selling counterfeit painkillers and other fake medications. About 20 illegal online pharmacies are launched every day.

A staff report last week to the U.S. Senate's Subcommittee on Investigations found that it was relatively easy to find and order prescription drugs online. Senate investigators used Google search to find dozens of websites offering illegal opioids for purchase, including fentanyl and carfentanil. They also identified seven individuals who died from fentanyl-related overdoses after sending money and receiving packages from an online seller.

“I’m thrilled this is something the U.S. government is prioritizing and is starting to pay attention to,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies (ASOP), an industry supported non-profit. “The Internet is part of the problem right now when it comes to the opioid epidemic and it should be part of the solution.”

Baney told PNN that when illegal online pharmacies are shutdown, they often reappear under new domain names and website addresses. Many are also located in foreign countries and are outside the reach of U.S. law enforcement.

“It’s a game of whack-a-mole in some respects,” said Baney.  

Last year the Justice Department announced the seizure of the largest dark net marketplace in history, a site that hosted over 200,000 drug listings and was linked to numerous opioid overdoses, including the death of a 13-year old.

Business Booming for Illegal Online Pharmacies

By Pat Anson, Editor

One of the many unintended consequences of efforts to reduce opioid prescribing is that they may be fueling the growth of illegal online pharmacies.

According to one estimate, as many as 35,000 online pharmacies are in operation worldwide. Over 90 percent are not in compliance with federal and state laws, many do not require a prescription, and about half are selling counterfeit painkillers and other fake medications. About 20 illegal online pharmacies are launched every day.

“There is no sign that this is slowing down,” says Libby Baney, Executive Director of the Alliance for Safe Online Pharmacies (ASOP), an industry supported non-profit.

“You have people (losing) their access to healthcare, not just pain care, but just general care. You have the opioid epidemic. You have the well-intended policy responses to that. All of this has the potential, unintended consequence of sending people to the Internet.

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“My biggest fear is that if you limit prescriptions to five days or seven days, or prevent access to medication altogether, and people search.”

Since 2015, counterfeit painkillers and other medications made with illicit fentanyl have killed Americans in at least 16 states, according to a recent report that found the highly dangerous pills have spread from coast to coast.

"A lot of these people are buying it on the street or the Internet," Dr. Karen Gunson, Oregon’s medical examiner, told The Oregonian. "They think they're buying oxycodone or Xanax pills but they don't know what they're getting.''

What pain medications can you buy online? Oxycodone, hydrocodone, Percocet, Vicodin, tramadol and other painkillers can easily be found online, along with other controlled substances that are becoming harder for patients to obtain legally.

“There are thousands of websites that have figured it out and people are using them,” says Baney. “Most of these sites are based offshore. They may be using some U.S. servers, U.S. bank accounts or U.S. domain registrars, but nearly all are offshore. And that creates law enforcement hurdles.”

Last month the Food and Drug Administration announced a crackdown on over 500 online pharmacies that were accused of selling illegal and potentially dangerous medications. Warning letters were sent on September 19, giving the website operators 10 days to stop selling unapproved or misbranded prescription drugs.

Twenty days later, most of them are still online selling the same medications.

In a chat today with “Peter” at one of the websites that received a warning letter, I was told that I could purchase 80mg tablets of oxycodone without a prescription. Another website offered to ship us medications “placed inside baby doll as gift to ensure customer privacy and safe delivery.”

Baney says many of the illegal online pharmacies act as marketing agents for foreign drug suppliers.

“You don’t even need to have your own drug supply,” she said. “All you have to do is join an affiliate network and basically become a third-party marketer for an existing drug network.

“They give you the website template. They have the bank account setup. All you need to do is put up the site and process orders, and you get a cut and they get a cut, and they ship the drugs. It’s a pretty slick deal.”

Baney says it’s relatively easy to tell the difference between a legitimate online pharmacy and an illegal one. The URL’s for websites that end with “.Pharmacy” (not .com or .net) are certified by the National Association of Boards of Pharmacy and are in compliance with laws and practice standards.

You can also visit buysaferx.pharmacy to verify whether a website is legitimate.

The ease and convenience of ordering medications online – as well as the demand and profitability -- haven't gone unnoticed. According to CNBC, Amazon in the next few weeks will decide whether to enter the $560 billion prescription drug market with an online pharmacy of its own.

FDA Targets Rogue Online Pharmacies

By Pat Anson, Editor

The Food and Drug Administration is cracking down on over 500 online pharmacies that illegally sell potentially dangerous, unapproved versions of prescription drugs, including opioid pain medication, antibiotics and injectable epinephrine products. So far the crackdown doesn’t appear to be very effective, as many of the websites the FDA targeted remain online.

The FDA recently partnered with Interpol and other international law enforcement agencies in a global operation called Pangea X. The goal was to identify the makers and distributors of illegal prescription drugs and shut them down.

“These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully distribute illicit drugs, including counterfeit medicines and controlled substances. Consumers go to these websites believing that they are buying safe and effective medications, but they are being deceived and put at risk,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

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“The ease with which consumers can purchase opioid products online is especially concerning to me, given the immense public health crisis of addiction facing our country. Some of the websites sold unapproved versions of multiple prescription opioids directly to U.S. consumers. This easy and illegal availability of these controlled substances fuels the misuse and abuse of opioids.”

The FDA sent 13 warning letters to the operators of 401 websites informing them they were illegally selling unapproved prescription drugs.

screen shot from american pharmacy group website

screen shot from american pharmacy group website

One such letter went to the American Pharmacy Group in Silver Spring, Maryland, warning the company about selling an unapproved combination of hydrocodone and acetaminophen in 10/500mg doses.

The FDA asked drug manufacturers in 2011 to limit the strength of acetaminophen in prescription drugs to 325mg because of the risk of severe liver injury.

“There are currently no approved drug applications… for the hydrocodone products that contain 500 mg of acetaminophen offered for sale on your websites,” the FDA letter warned.  “Offering hydrocodone products for sale on your websites is particularly concerning given the potential for abuse and dependency, especially amid the growing epidemic of opioid abuse in the U.S.”

The FDA letter was dated September 19, 2017. But today a website affiliated with American Pharmacy Group was still selling the hydrocodone/acetaminophen combination in the 10/500mg dose as a “muscle relaxant.” A bottle of 30 pills could be purchased for $269 with 2-5 day delivery.  

In an online chat with “John” the pharmacy manager, I asked if a prescription was needed to get the painkiller.

“No you no need prescription no,” was his reply.

“Really? I don’t need a prescription to get that?” I asked

“No,” he answered again.

John then referred me to a “new” online pharmacy, one that was not on the list of 21 websites the FDA identified as being affiliated with American Pharmacy. It’s apparently easier to put a new website up than it is for federal agents to take an old one down.

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In adddition to warning letters, the FDA seized nearly 100 website domain names, such as buyhydrocodoneonline.com, canadian-pharmacy24x7.com and buyklonopin.com.

As part of Pangea X, FDA inspectors also screened packages suspected of containing illegal drugs at international mail facilities (IMFs) in Chicago, Miami and New York. Those screenings resulted in nearly 500 parcels being seized.

“Our work to fight illegal online pharmacies is not over,” said Gottlieb. "We’ve recently tripled the staff we have in the IMFs to improve our ability to inspect packages that are suspected of containing illegal drugs, and we have doubled the number of cybercrime and port of entry special agents for the Office of Criminal Investigations,” Gottlieb said.

Interpol said it seized over $51 million in illicit and counterfeit medications during Operation Pangea X. Over 400 people were arrested worldwide, with 3,584 websites shut down.