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FDA Focuses on Illegal Fentanyl Imports, Neglects Off-Label Prescribing

FentanylThe FDA has made it it’s business to shine a bright light on the evils of illegal fentanyl imports, which are sometimes sold online. That focus seems like it’s a good one. Illegal fentanyl imports get into the hands of drug dealers who use the ingredients to make counterfeit, opioid-based drugs. They sell them to addicts who too often overdose and die. I’ve written a lot about the FDA’s crackdown on illegal fentanyl imports being misused to stop imports of prescription medicines on their way to American patients from Canada and other countries. However, something much more troubling actually has gone down over the past few years.

According to documents obtained through a Freedom of Information Act request by the John’s Hopkins Bloomberg School of Public Health, the FDA ignored information about off-label prescribing of the most dangerous prescription opioid drugs: fast-acting fentanyl or transmucosal immediate release fentanyl (TIRF). Those drugs were approved to treat the most serious pain experienced by cancer patients. Instead, drug companies encouraged off-label prescribing for patients experiencing lower levels of pain and certainly did not have terminal illnesses.

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Real Opioid Online Drug Dealers Indictment Unrelated to Rx Import Savings

Indictment of Evelin Bracy and Jorge Rodriguez Lopez Here’s a real story about online opioid drug dealers getting indicted and how pharma front groups conflate the opioid crisis with prescription drug importation. I write “real” to juxtapose rogue online pharmacies—that illegally sell addictive drugs—and safe international online pharmacies that don’t sell addictive drugs at all.

On July 9th, the U.S. Department of Justice for the Southern State of New York announced the indictment of Evelin Bracy and Jorge Rodriguez Lopez for illegal distribution of controlled drugs, including an analog of the opioid pharmaceutical Fentanyl – called U-47700. They are also accused of selling these drugs on the Internet from what the DOJ refers to as a website “purporting to be an online pharmacy.” The indicted parties were also alleged to have sold drugs under pharmaceutical names, oxycodone and alprazolam, that were found to have other ingredients, implying that the products were counterfeit. These counts can technically land a person in jail for 40 years.

If the allegations are true, then we’re dealing with bona fide drug pushers. The Partnership for Safe Medicines (PSM), a Pharma-funded non-profit group that seeks to conflate such drug dealing and counterfeiting with pharmacies in other countries that sell affordable prescription medicines to people here in the U.S. PSM is keeping a web diary of law enforcement busts that help stop the deadly fentanyl trade, which is taking the lives of thousands of Americans each year. We applaud law enforcement for disrupting these opioid dealing operations and bringing their orchestrators to justice.

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FDA Plan to Seize Illegal Opioid Imports Could Affect Prescription Deliveries

As reported by the Associated Press, FDA Commissioner Scott Gottlieb announced a plan earlier this month to stop imports of opioid drugs by doubling the number of inspectors at international mail facilities. This type of targeted enforcement against opioid drug products is the stuff of real public health protection, but it can easily be misused to refuse online pharmacy orders of prescription medication imports. Millions of Americans are ordering medications from abroad because they cannot afford the exorbitant prices here in the United States. Prescription medication orders from licensed pharmacies in Canada and other countries should not be conflated with illegal importation of opioids.

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Were you prescribed opioids instead of OTC pain meds?

According to a new study, it turns out that, potentially, millions of people should have been prescribed over-the-counter drugs—not addictive narcotics. That’s a major finding considering 600,0000 Americans have died from drug overdose between 1999-2016. The Journal of the American Medical Association (JAMA) study shows that over-the-counter medications, such as ibuprofen, acetaminophen, aspirin and naproxen may work better than the hard, addictive stuff, such as Vicodin, Oxycontin, and Fentanyl.

We recognize and respect the role that properly prescribed prescription narcotics have played and will continue to play in pain management. However, we also believe that Big Pharma makers and sellers of opioids caused this national crisis of drug addiction by helping to create looser prescribing rules. In other words, while at one-time opioid medications were viewed as a last resort to treat serious pain, drug companies pushed medical education that led to the prescribing of opioid drugs. The U.S. Centers for Disease Control and Prevention has revised its guidelines to encourage far tighter prescribing practices, but, as this study indicates, their revisions came way too late.

Patients Who Took Opioids

The JAMA study looked at 248 patients with varying levels of pain, back pain being the most prevalent form affecting 65% of patients. Others had pain associated with hip, knee and that associated with osteoarthritis. One group of patients were prescribed opioid medications. They started with fast acting morphine, a combination of hydrocodone and acetaminophen, or oxycodone. Long acting medications, morphine or oxycodone, were used when the short acting treatments were not working. When those did not work, fentanyl patches were prescribed.

Patients Who Took Non-opioids

Another group took NSAIDs. If NSAIDs did not work, then the group took other prescription medications, such as gabapentin (Neurontin) or pregabalin (Lyrica). If those didn’t work, then tramadol, which is an opioid-based painkiller but less addictive than the ones in the opioid group.

Results of the Study

Patients in the non-opioid group reported equal or better results in pain alleviation than patients in the opioid group. Admittedly, I’m confused because tramadol was in the non-opioid group, even though it’s an opiate-based medication. Also, one shortcoming variable of the study is that patients knew what medications they were taking, which could have biased their reporting.

Overall, the study strongly demonstrates that millions who were prescribed strong opioid drugs and became hooked could just as well have been treated initially with regular OTC pain medications. Not surprisingly, patients could have also saved billions of dollars over the last few decades by taking aspirin instead of brand-name prescription opioids.

This has really caught my attention because the industry-funded groups like the Alliance for Safe Online Pharmacies and Partnership for Safe Medicines equates importation from Canada with the opioid crisis. Instead of urging people to seek alternatives to opioids, the pharmaceutical industry propagates the senseless idea that increasing imports of lower cost (non-pain) medications from Canada will worsen the opioid crisis. They would rather point fingers than address the sickness of their complicity in creating the drug addiction crisis in the first place.

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