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 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 | Feb 13, 2015 | Advocacy, Drug Safety, Online Pharmacy Verification Services
When it comes to prescription drugs and the public health, safety and affordability have to be considered together. People are at risk if they obtain medication that doesn’t work because it’s counterfeit, adulterated or substandard. At the same time, a perfectly safe and effective prescription drug will not help someone who cannot afford it. We help protect the public health by obtaining, verifying and providing information about online pharmacies and prescription drug prices that consumers can use to help maximize access to safe and affordable medication.
As we’ve said time and again, the key is to stay away from rogue online pharmacies by sticking with pharmacy sites publishing a valid PharmacyChecker.com seal, or accreditations from the Verified Internet Pharmacy Practice Sites program or LegitScript. Many members, but not all, of the Canadian International Pharmacy Association are verified by PharmacyChecker.com as well.
For healthcare providers and consumers looking to understand who we are, what we do, and how to use our information, we publish “Protecting the Public Health: Verifying Pharmacy Websites to Help Consumers Find Affordable Medication and Avoid Rogue Online Pharmacies.”
For those interested in more specifics on our online pharmacy safety policies, requirements and standards please see our detailed guidance document about our verification program.
We welcome your questions or comments about our programs and policies: info@pharmacychecker.com.
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jan 23, 2015 | Counterfeit Drugs, Drug Safety
FDA Seized Counterfeit Cialis at International Mail Facility
The FDA issued a warning about counterfeit Cialis, an erectile dysfunction (ED) medication, being sold through the mail, which probably means it was purchased from a rogue online pharmacy. The fake Cialis is some whacky combination of Cialis’s active ingredient, tadalafil, and the active ingredient in Pfizer’s Viagra, called sildenafil. Apparently, the FDA seized the counterfeit product before it reached a consumer in the U.S. by mail.
Fortunately, over 99% of safe, personally imported prescription drugs are not seized at international mail facilities. Still, I’ve given the FDA considerable grief about seizing safe medications, which they usually deem “misbranded” or “unapproved” for intellectual property or labeling reasons – but in this case FDA protected someone from a bad drug and that’s cool.
According to Reuters, FDA “cautioned against purchasing prescription medicines online, noting that some websites may be selling unsafe products.” The FDA also said that there is no indication that the “legitimate supply chain” – meaning the U.S. domestic supply chain – is at risk and that licensed U.S. pharmacies are safe. That’s probably true but there’s no reason to believe that the legitimate supply chains in other countries aren’t safe either. In other words, foreign online pharmacies verified by PharmacyChecker.com continue to sell real Cialis, the one marketed by Eli Lilly, for a lot less than they do here. The lowest cost Cialis (10mg) is $14.25 at a PharmacyChecker.com-approved international online pharmacy. That compares with a whopping $44.92 per pill at a one of the lower cost VIPPS-approved online pharmacies (VIPPS is the online pharmacy verification program of the National Association of Boards of Pharmacy).
The FDA recommends that consumers do not take Cialis supplied in bottles matching one or more of the following descriptions:
- lists “AUSTR81137” on the front of the bottle;
- does not include an NDC number on the front of the bottle, such as “NDC 0002-4462-30” for the 20 mg tablets;
- does not include the tablet strength in a colored box;
- has different patterns and colors; it has yellow and darker green designs on the front label;
- has misspellings; it lists, “CLALIS is a product of: Eli lilly Australia PTY Limited” on the side of the bottle;
- lists the manufacturer location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle; and
- lists “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle.
I don’t agree with one of these – the bolded one – and here’s why: safe and real Cialis, or other genuine medications, ordered from online pharmacies won’t necessarily have an NDC number on it. In fact, if you were to travel to another country and purchase meds, real prescription drugs, in a brick-and-mortar pharmacy, they would not have an NDC number. That’s because NDC is unique to drugs packaged for sale in American pharmacies. Other countries use different labeling systems; for example, Canada’s version of NDC is called DIN (drug identification number).
One last important note: the truth is that many people want to get ED meds online, whether it’s Viagra, Cialis, or Levitra, without a prescription. PharmacyChecker.com strongly recommends that you don’t do that. The studies show that online pharmacies that don’t require a valid prescription are more likely to sell fake or otherwise bad medication, especially bogus ED meds!
Tagged with: cialis, Eli Lilly, Pfizer, Viagra
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Aug 22, 2014 | Advocacy, Drug Safety, Internet Censorship, Online Pharmacies, Rogue Online Pharmacies
I’m writing this blog post to say thank you to a domain registrar called EasyDNS and its CEO, Mark Jeftovic, and to talk about what’s up with registrars and online pharmacies, as it could affect your online access to safe and affordable medication. EasyDNS’s new online pharmacy policy denies service to rogue online pharmacies but not safe online pharmacies. It will accomplish this policy by providing service to online pharmacies only if they are approved by LegitScript or PharmacyChecker.
In short, domain registrars are companies that help people obtain website names; names such as www.rxrights.org, www.doctorswithoutborders.org, www.WebMD.com, www.nytimes.com, etc. The most popular of these registrars in America is Go Daddy. If all registrars deny service to a person or a company, such as a rogue online pharmacy, then it cannot reach the public. If all registrars deny service to safe online pharmacies with very low drug prices then the public will not have access to them.
Our friends at RxRights gave a strong shout out to EasyDNS this week as well.
You might be thinking that this is no big deal. Who wouldn’t want to stop rogue pharmacy sites but allow safe, low-cost online pharmacies to operate? Well, earlier this year the National Association of Boards of Pharmacy (NABP) sent letters out to 200 registrars telling them to take down websites that NABP doesn’t recommend. No matter how safe it might be, the NABP does not recommend any international online pharmacy that sells to Americans, instead unfairly calling them rogue sites.
Popular Internet freedom blog Techdirt published an article about NABP called, “Pharmacy Group Lies To Registrars: If We Complain About A Site, It Must Be Taken Down No Questions Asked.” It wrote: “The NABP is basically an organization designed to artificially inflate the price of drugs in the US, cynically using highly questionable claims to pretend that they’re focused on ‘public safety.’”
For the record, there is not a single reported death by a person who ordered from an international online pharmacy, ones that NABP calls “rogue,” that requires a valid prescription and fills orders through licensed pharmacies. The industry has been around for about fifteen years now. (more…)
Tagged with: Alliance for Safe Online Pharmacies, EasyDNS, LegitScript, NABP, Registrars
