by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | May 22, 2015 | Counterfeit Drugs, Drug Safety, FDA, Personal Drug Importation
A story last Friday on ABC News’s 20/20 featured the topic of counterfeit drugs, their dangers and where they’re being sold. The story was helpful in educating the public about the threat of counterfeit drugs but it really seemed to play along with a misleading narrative, one propagated by the drug companies, that foreign medications are the same as counterfeit drugs. I’ve debunked this nonsense before: affordable and safe medications sold from foreign pharmacies are not the same as counterfeit drugs.
Also, as part of its feature on counterfeits, ABC’s website has a section called “How to Order Prescription Drugs Safely Online” that looks to the Alliance for Safe Online Pharmacies (ASOP) for useful consumer information. ASOP is financed and operated by big corporate pharmaceutical interests that oppose personal drug importation from safe online pharmacies. If you have great health insurance that covers all of your medications, or lots of money to cover exceedingly high out of pocket prescription drug costs, then the recommendations of ASOP might work for you because they recommend big U.S. chain pharmacies, such as Walgreens and CVS, which charge the world’s highest prices for medication. Many other Americans actually NEED safe international online pharmacies, which ASOP would call unapproved or even “rogue.”
It its story, ABC investigative journalists tracked down people selling prescription medications on the street, from push carts, even in clothing stores – usually in relatively poor neighborhoods. Eventually those people were arrested, all for the viewing audience to see. According to the federal agents involved, some of the medications seized were counterfeit and people did not have to provide a prescription to buy prescription drugs. The story was very troubling. Indeed, it was a powerful indictment of our society, one in which drug prices are so outrageously high that people, such as undocumented immigrants without health insurance, look to street peddlers to find affordable medication.
ABC also covered what are known as “Storefront” pharmacies, which are located throughout the country, often in strip malls, where people go to buy medications from pharmacies in other countries by mail order. These storefronts usually have titles that include the words “Canada,” or “Canadian,” and “Drugs,” “meds,” “medicine,” “Rx,” etc., which indicate that a person can acquire medicine from Canada. ABC wanted to highlight that the medications ordered at these places often do not come from Canadian pharmacies but from other countries. ABC’s implication is that people are being misled. On the other hand, when watching the show, it appeared that storefront personnel did communicate that the orders would not come from Canada so I’m not clear on what’s going on here. We wrote a piece about online pharmacies related to this issue: “So You Want to Buy Cheap Medicine from an Actual Canadian Pharmacy. Here’s the Deal.”
We do not verify storefronts but we believe that some of them are essentially people and companies that help Americans place prescription drug orders from foreign pharmacies that require a valid prescription. In fact, through ABC’s mystery shopping (meaning purchasing prescription drugs from storefronts) they were required to submit valid prescriptions and did so. A few weeks later the journalists received four medications, two of them brand, Viagra and Zocor, coming from Singapore and the UK, and two generics, tadalafil (the brand version known as Cialis) and finasteride (the brand version known as Propecia), both Indian drug products.
The story made it seem as if the two generics were either substandard or counterfeit, as it was noted they contained “impurities” or “unknown ingredients”. What ABC News did not communicate is that the so-called “impurities” or “unknown ingredients” might be acceptable inactive ingredients, excipients, etc., just different from those in the brand versions sold in the U.S. This is normal: generic drugs in the U.S. often have different inactive ingredients from their brand name counterparts. When the Indian generics were chemically tested, ABC showed the results as “fail” but didn’t tell you that generics sold in U.S. pharmacies would likely have failed as well if given that same test because they are not the exact same as the brand in terms of inactive ingredients.
Also, when ABC reported that most of the medicines did not meet FDA standards, it didn’t explain that simply having a label designed for a different country automatically means it does not meet FDA standards, regardless of the medication’s actual safety. In short, foreign sourced medications are often safe and effective products, approved for sale in the countries from which they are dispensed – but not counterfeit or substandard.
It’s important to note that the generics received by the journalists came from India, and, as we’ve written about before, India does have more problems with low quality and counterfeit drugs than in the U.S. or other rich countries. At the same time, India is the largest source of generic medications, exporting across the globe to wealthy, middle income and poor countries. In fact, 40% of generics sold in U.S. pharmacies are from India. It’s well known that the top Indian drug companies excel at making high quality, safe and effective prescription medications, but even among them problems exist, too.
On a closing note about ABC’s coverage of counterfeit drugs, I encourage our readers to look at the consumer comments section on ABC’s website. People don’t believe the big drug company propaganda, or even our trusted regulatory authorities like the FDA. That bothers me because the FDA is right that there are rogue pharmacy operators out there, often online, but they’re wrong not to acknowledge the relative safety and public health benefits of safe international online pharmacies. Hopefully ABC will really investigate…
Tagged with: 20/20, ABC News, Alliance for Safe Online Pharmacies, Storefront
by PharmacyChecker.com | May 15, 2015 | FDA, Online Pharmacies, Policy, Politics, Rogue Online Pharmacies
There are potentially tens of thousands of dangerous pharmacy websites, sometimes referred to as “rogue online pharmacies,” polluting the Internet and endangering the health of consumers worldwide. There are a much smaller group of safe domestic online pharmacies. Then there are an even smaller group of safe international online pharmacies, ones that we have verified, that sell many medications at much lower cost. However, when Americans purchase from these international online pharmacies (often because they can’t afford medication domestically) and import safe and effective medications, they are under most circumstances violating U.S. laws, which poses a quandary for regulators, public health officials, and even some people working over at Big Pharma. What’s right and wrong? How do we get rid of the rogues without overreaching and endangering public health by stopping Americans from obtaining safe medication internationally over the Internet?
In our continuing quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing the next section of our report called Online Pharmacies, Personal Drug Importation, and Public Health…
(more…)
Tagged with: Bing, CanadaDrugs.com, CSIP, DNS locking, FDA, GAO, Google, LegitScript, NABP, Newpharm.net, Operation Pangea, rogue online pharmacy, rogue pharmacies
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Apr 23, 2015 | Drug Safety, FDA
PharmacyChecker.com’s focus is on helping consumers find safe and affordable meds online while avoiding rogue pharmacy websites. But what do people do with unused medication? Leaving unused prescription drugs in medicine cabinets at home can leave them susceptible to abuse or accidental ingestion. Unused medication includes those products that you no longer need or that are expired. Disposal methods include bringing medication to “take-back” programs in your community, safely throwing in the trash, and even flushing meds down the toilet – but there are important guidelines to ensure safety.
Medication disposal is a particularly critical issue when it comes to controlled drugs, ones susceptible to abuse, because prescription drug abuse has reached epidemic proportions in the U.S. About seven million Americans abuse prescription drugs, often powerful narcotics, such as oxycodone and Adderall, almost twice the number found to abuse illegal drugs, such as heroin and cocaine. About 70% of first time abusers get the drugs from friends or relatives, including from their medicine cabinets!
The U.S. Food and Drug Administration (FDA) recommends following the disposal instructions on the label of the drug. Don’t flush your meds down the toilet except when instructed to do so. Your community will likely have drug “take-back” programs. Call your local government offices to find them. In the absence of instructions or take back programs, the FDA recommends throwing most medications away in the household trash. Mix loose medication in a sealable bag or container with an undesirable substance such as coffee grounds or litter. It’s also recommended that you remove or scratch out any information on the prescription label so that it’s unreadable.
The FDA recommends flushing narcotic pain relievers such as fentanyl patches, morphine, Demerol, Percocet, and OxyContin, among many others, as soon as they are no longer needed because of their high risk of abuse. There are environmental concerns related to flushing medication, such water contamination. However, according to the Environmental Pro¬tection Agency, scientists to date have found no evidence of adverse human health effects from pharmaceutical residues in the environment. FDA provides a complete list of medications for flushing here.
Before throwing disposing of any medication, the FDA also recommends removing the labels on pill bottles to remove any information others might use
Drug and regulatory authorities have recently stepped up options for prescription painkiller disposal to combat the addiction epidemic. In fact, a relatively new FDA rule now allows pharmacies, doctors’ offices, and hospitals to collect controlled substances from consumers. The DEA has launched a drug collection site database to help you find one. The public may find authorized collectors in their communities by calling the DEA Office of Diversion Control’s Registration Call Center at 1-800-882-9539
What about destroying your medication?
There are products on the market for consumers and healthcare providers for disposing of medications. We DO NOT ENDORSE them but here are a few that may meet your needs help you follow the advice noted above:
Medsaway Medication Disposal System
Pill Terminator
Disposing of your medication responsibly improves safety for you, your loved ones, and everyone else that may come into contact with it.
Tagged with: Adderall, Demerol, Environmental Protection Agency, FDA, fentanyl, morphine, oxycodone, Oxycontin, Percocet
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Mar 20, 2015 | Drug Safety, FDA, Generic drugs
As we all know, an unaffordable drug is neither safe nor effective. No less true, an ineffective drug, whether dirt cheap or super expensive, can have hazardous health consequences, even death. That’s why consumers seeking low cost medication online look to avoid bad meds by finding accredited online pharmacies with a PharmacyChecker or VIPPS seal. But that might not always be good enough…
People don’t like to talk about it but sometimes switching from a brand name med to an “equivalent” generic can lead to serious health problems. And this happens at your local U.S. pharmacy, not just online. Tod Cooperman, MD, president of PharmacyChecker.com, knows about this more than most people. In his capacity as president of ConsumerLab.com, he participated on an expert panel at a Congressional briefing this past Wednesday, organized by a new group called the Safe Medicines Coalition led by economist and counterfeit drug expert Roger Bate, PhD. The panelists and others are authors of a new paper called “Drug Inequality: Allowable Variations and Illegal Underperformance in Off-Patent Drugs.”
Dr. Cooperman’s main contribution to the panel comes from his experience testing a generic version of the anti-depressant Wellbutrin XL. To make a long story short, in 2007 ConsumerLab.com tested Teva’s FDA approved generic of the 300 mg version called Budeprion XL – an extended-release product. A generic drug that is bioequivalent to the brand name drug is supposed to work pretty much the exact same way as the brand. Consumerlab.com found that Teva’s generic did not dissolve like Wellbutrin XL – it released the drug much too quickly. It took the FDA more than 5 years but it finally conceded that the product was not bioequivalent to the brand product because it released the active ingredient much faster.
According to the People’s Pharmacy, people taking this generic were feeling more depressed, and even suicidal – until they switched back to the brand or to a different generic. The People’s Pharmacy and ConsumerLab.com shared this information with the FDA back in 2007 only to be ignored.
In order for the FDA to approve a generic drug for sale in the U.S., it must be proven to be bioequivalent to the brand name drug –delivering approximately the same amount of drug over the same amount of time in a group of healthy volunteers. It turns out that Teva never did this for the 300 mg version of Budeprion XL. The FDA approved the drug anyway, based on the data and approval for a lower strength version, Budeprion XL 150mg. What’s more amazing is that generic medications, even though they are not the exact same as their brand name counterparts, under U.S. law, must have the exact same clinical data in their package inserts as the brand name drug. That is, the data shown in the insert is NOT actually the data for that generic. This is meant to give the impression that all generics are the same as the brand name product, even though that’s not the case. If that doesn’t seem to make sense then you’re thinking clearly.
In 2012, the FDA admitted ConsumerLab.com had been right, and stated that Budeprion XL 300mg is was not bioequivalent to Wellbutrin XL 300mg.
Dr. Harry Lever, a cardiologist, talked about patients who were not responding well when switched to certain generic heart medications, such as beta blockers. Most interestingly, problems not only occurred when patients switched from brand to generic but even from generic to generic, which takes us back to the efforts of ConsumerLab.com above and moves us into a new point: Not all generic drugs are equal to each other, and a particular generic might work better in one patient than another!
The key takeaway from Dr. Lever’s and Dr. Cooperman’s presentations is that if a certain generic drug is working for you, then try and stay on that exact same medication. You’ll find it’s not easy because pharmacies often interchange generic drugs in their dispensing practices. You can avoid this by making sure you ask for the same generic, meaning the same manufacturer, each time you visit the pharmacy.
Mr. Bate focused on the fact that drug quality, generally, is not equal from manufacturer to manufacturer, brand to generic, generic to generic, country to country, etc. Mr. Bate is not saying that most generic drugs don’t work but simply that they are not exactly the same. Dr. Preston Mason supported this by presenting data based on testing generic versions of Pfizer’s Lipitor. He found that different versions were not all equal. The lowest quality products, based on number of impurities, were made in India for export to poorer countries.
The final presenter was Dinesh Thakur, the whistleblower that outed major manufacturing problems and corruption at Indian drug manufacturer Ranbaxy. Ranbaxy was actually granted the first go at marketing generic Lipitor in the U.S., but their version was eventually recalled due to small particles of glass that may have contaminated the product. You might find FDA’s nuanced position on the recall instructive and of great interest: “Patients who have the recalled medicine can continue taking it unless directed otherwise by their physician or health care provider….To date, FDA hasn’t received any reports of injury….The possibility of adverse health problems related to the recalled atorvastatin is extremely low.” I don’t recall hearing that the drug was not effective either but its recall was precautionary.
So what the hell are average consumers and even their healthcare providers to make of all of this? I’m going to copy and paste from ConsumerLab.com:
- If a generic doesn’t work like the original drug, be concerned, particularly if it is an extended release (often called “XL”) product.
- Be aware that the labeling on a generic drug describing its performance is copied from the labeling of the original product and may not reflect the performance of the generic. This is a deception required by the FDA, perhaps to create the perception of generics as interchangeable.
- If a generic works for you, look carefully at the label and identify the manufacturer. Request the same manufacturer each time you refill that prescription. Other generics may not behave the same way.
From my perspective, despite the FDA debacle with generic Wellbutrin XL discussed above, the FDA is one of the best drug regulatory agencies in the world. Following the advice above, you can and should trust generic drugs sold in the United States. What about generic drugs sold over the Internet from foreign countries? Pharmaceuticals sold in the most highly regulated countries are generally equivalent in quality and efficacy to those sold in the United States. What about from Indian pharmacies? The highest quality medications sold in Indian pharmacies are on a par with those sold in the U.S., too, but there’s more deviation and far too little oversight from the Central Drugs Standards Controller Organization, India’s FDA.
For all of these reasons, if you’re buying online and getting a drug internationally stay away from websites that are not credentialed by PharmacyChecker.com. And remember, despite crazy price increases in a good number of generic drugs, most generic medications approved for sale in the U.S., sold at local pharmacies are less expensive than International online pharmacy prices – even cheaper than India! However, brand name products are usually far less expensive outside the U.S. (and apparently sometimes safer than generics) – and you can check those prices on www.PharmacyChecker.com.
Tagged with: Consumerlab.com, Roger Bate, Safe Medicines Coalition, Tod Cooperman, VIPPS
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Oct 23, 2014 | Counterfeit Drugs, FDA, Rogue Online Pharmacies
When you’re fighting for something you believe in sometimes you lose perspective, and that can lead to overreaction and self-righteous indignation. I’ve been very critical of the FDA because I believe the agency is not doing right by Americans consumers on the issue of online pharmacies and personal drug importation. FDA seems incapable of admitting that there are safe international online pharmacies that help Americans afford medication, and its BeSafeRx program is right out of the big pharma playbook; and…wait, wait, there I go again…
The FDA, specifically its Office of Criminal Investigations, expends a lot of time and energy tracking down people who are intentionally selling fake, expired, or otherwise clearly dangerous pharmaceuticals. Those efforts save lives and ought to instill fear in those perpetrating these acts or those considering doing so. We should and do applaud FDA for those efforts. (more…)
Tagged with: Enforcement, OCI, Office of Criminal Investigations, public health
by PharmacyChecker.com | Oct 14, 2014 | Advocacy, FDA
If you receive an e-mail or see a web page offering to sell you anything that cures, prevents, or treats Ebola, you can be sure it’s a scam. That’s because there currently aren’t any drugs that prevent or treat Ebola, though there are vaccines and treatments in the works. If you see any companies that sell these falsely marketed products, report them to the FTC or FDA.
For more, check out the FTC blog.
Tagged with: Ebola, FDA, FTC, Online Pharmacy Scams
