POLITICO Magazine.
The dark and deadly world of pharma spam.
December 16, 2014.
Part of the problem, Warner said, is that many unlicensed Internet pharmacies will happily ship a variety of drugs whose use has been banned or highly restricted in the United States because of the drugs’ tendency to induce dangerous side effects—without offering any warnings or instructions on using the medications.
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For example, pharmaceutical giant Roche decided to pull its anti-acne drug Accutane from the U.S. market after juries awarded millions of dollars in damages to former Accutane users. The drug has been strongly linked to birth defects among children born to women who took it while pregnant. As a result, the U.S. FDA in 2005 ordered that Accutane only be sold to women who sign a pledge saying they will submit to multiple pregnancy tests and practice at least two forms of birth control while on it. But Accutane is still available through rogue spam pharmacies.
This is another example of the risks people take when buying from these rogue pharmacies: They don’t get vital information on the serious health hazards they could face in taking certain drugs in certain conditions or in combination with other drugs. Legitimate pharmacies, on the other hand, do their best to ensure that their customers understand these risks before giving them their prescriptions.
“Many of these rogue pharmacies are still advertising a number of discontinued, banned or very restricted drugs,” Warner said. “And they’re definitely not passing on warnings about how these drugs should be used, even when there are strong conditions that would normally be impressed on the customer when ordering these drugs from regular pharmacies.”
The most obvious example of a common risk introduced by pills dispensed from GlavMed and SpamIt pharmacies is the two to four free counterfeit Viagra or Cialis pills that were shipped with every order. The pills were stuffed into all orders, even those in which the customer had purchased drugs such as nitrates that could produce a deadly cocktail when taken with erectile dysfunction (ED) medications. Physicians have long warned against taking ED drugs in tandem with medicines designed to decrease high blood pressure, because doing so could lead to dangerously low blood pressure levels, a condition that often precipitates a heart attack.
Despite our efforts, I was unable to get any of the online drug buyers to send me useful samples of the pills for testing in Gardner’s lab. Not that it would have mattered: UAB couldn’t get legal cover to do it anyway.
Incredibly, the UAB researchers have legal approval from federal regulators and law-enforcement agencies to test and handle highly controlled and illegal substances, such as cocaine, heroin and a methamphetamine, but they had not yet received permission from the FDA and DEA to test pills ordered through junk email.
Part of the problem is that Congress changed the law in 2008, when it enacted the Ryan Haight Act, which makes it expressly illegal for anyone to order prescription drugs over the Internet without a prescription. In addition, even if an American has a valid prescription for a drug, it is illegal for him or her to order the drug from a pharmacy outside the United States and have it shipped back into the United States.
“We’ve kind of gotten it taken care of,” Warner said. “We’ve got the memorandums of understanding in place and got the post office boxes all set up and the top-level approval at the university. But we still have this one tiny little administrative hurdle to get over.” They still needed a green light from federal regulators.
Warner even had a regional bank on board to provide his researchers with prepaid cards that could be used to covertly buy drugs from GlavMed-SpamIt and Rx-Promotion.
“The bank was willing to put up the money to help fund our operations, but we still needed a government letterhead memo basically saying that no one was going to go to jail for this,” Warner said. The university was slated to receive a grant from the FDA to conduct research on rogue pharmacies, but the grant would come with serious strings attached.
“They basically said that none of the money could be used to purchase drugs, and if any of the grant money is used to analyze drugs ordered from spam, then the grant will be withdrawn,” Warner said. “What changed between when the FDA tentatively offered the grant and these conditions? Nobody can say. They just said, ‘It’s not legal for us to authorize you to buy drugs.’ So the FDA Office of Compliance had to go back and revise the grant to only evaluate the websites in the spam emails, and we were no longer allowed to purchase the pills.”
This was not the first time Warner and UAB were frustrated in their attempts to test pills ordered through spam to conduct their research. Not long before I’d shared the GlavMed data with him, Warner had a meeting with executives and fraud investigators from Pfizer. The pharmaceutical giant indicated it was interested in working with UAB on a study to analyze drugs purchased through rogue pharmacy affiliate programs. After all, counterfeit sales of its blockbuster drug—Viagra—accounted for more than 40 percent of the transactions from both Rx-Promotion and GlavMed.
But the funding for such a project would come with certain strings attached. “Pfizer said they wanted to work with us on this project as long as they had the right to shut the thing down if it turned out the drugs were real,” Warner recalled.
Ever Wondered Who’s Behind Those Viagra Emails? Brian Krebs – POLITICO Magazine
