Continuing our 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 a section a week of our report called Online Pharmacies, Personal Drug Importation, and Public Health. This week we look at the reasons why Americans look online to buy medication:

High U.S. drug prices are one of the main reasons that Americans go online to buy medication. As stated previously, according to the CDC, about five million Americans buy medication internationally each year due to high domestic drug prices. The CDC’s figures and others identified below show that over the past 15 years, tens of millions of Americans have purchased medication from outside the U.S. using online pharmacies to save money or because they could not afford the prices at their local pharmacies. Fifty million Americans between the ages of 18 to 64 did not fill a prescription in 2012 due to cost, up from 29 million in 2001. The data demonstrates that Americans need international online pharmacies due to a public health crisis of high domestic drug prices.

There are other reasons Americans go online to buy medication besides cost. Online pharmacies offer convenience and anonymity. For some consumers with mobility problems or for those who live in rural locations, ordering online and receiving medication by mail can be very helpful. Others may feel embarrassed about their medical conditions, which are sometimes unintentionally disclosed at their local pharmacy counters, preferring to order privately online.

Unfortunately, some Americans go online seeking medication without first obtaining a prescription from their healthcare providers. Many such people should not be judged. Americans who are uninsured may be unable to afford the medical care necessary to get a prescription and shop from online pharmacies that do not require one. Others just don’t want the “hassle” of going to the doctor and getting a prescription. There are obvious and inherent dangers in taking certain medications without first consulting with a licensed prescriber. Additionally, online pharmacies, foreign and domestic, that do not require a prescription are more likely to sell falsified and substandard medication and not ship medication safely.

Growing numbers of insured Americans in the coming years, a result of the Patient Protection and Affordable Care Act, will lead to a decline in medications ordered online without a prescription. However, many newly insured will find that their prescribed medications are not covered by their plans and are too expensive to pay for out-of-pocket at a U.S. pharmacy. For some, international online pharmacies are the only route to obtaining needed medication.

Finally, some Americans looking to obtain prescription narcotics without a prescription turn to the Internet, but the prevalence of such purchases are a small part of America’s prescription abuse problem. Still, the most serious negative health consequences related to prescription drugs bought over the Internet are from controlled drugs purchased without a valid prescription. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which largely banned online prescribing for controlled substances, was named after 18 year-old Ryan Haight who purchased prescription narcotics from an online pharmacy based in Oklahoma without a valid prescription and died from an overdose.

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When a Canadian Online Pharmacy Isn’t Just Canadian

An article by Joe Rothstein in EIN News concerning personal drug importation and online pharmacies recently caught our eye for two reasons. First, Mr. Rothstein called out the pharmaceutical industry for funding groups that give poor advice to consumers about buying medication online. Second, Mr. Rothstein identified PharmacyChecker.com as a source for “providing a list of certified Canadian suppliers who sell at prices usually well below the cost of U.S. pharmacies.” It is true that we do that, but our efforts extend far beyond Canada; we also verify and inspect pharmacies in many other countries, which was not mentioned in the article.

So what’s the issue? Remember, that according to the FDA, personally importing medication under most circumstances is technically illegal. Of course, many of us believe that it can be and is done very safely. Mr. Rothstein’s article states “…defenders of the importation law argue that thousands of phony online sites claim to be ‘Canadian’ to fool the unwary, and for self-protection consumers should avoid Canadian sites entirely.” Opponents of personal drug importation use those quotes around Canadian because they believe that dangerous rogue online pharmacies deceive consumers by claiming to be Canadian, only to ship medication from another country. On this count we agree with Big Pharma, however there are also safe Canadian online pharmacies that do refer prescription orders to licensed pharmacies in other countries.

PharmacyChecker.com verifies companies like this, making sure that every pharmacy a medication is shipped from is licensed and requires valid prescriptions.

Today, international online pharmacy takes place in a global marketplace. Yes, the history of Americans importing drugs for personal use begins with Canada (and even Mexico), when in a pre-Internet age Americans would cross the border to buy cheap meds. Then a crop of Canadian pharmacies began to operate online. In 2004, we began verifying pharmacies in several other countries that filled order for online Canadian pharmacies in our program. Canadian pharmacies were going global in part because drug companies actually cut supplies to pharmacies based in Canada that mailed prescription drugs to Americans, and also to offer medication from countries with lower prices than Canada.

So what’s the difference between a rogue “Canadian” online pharmacy and a verified Canadian pharmacy website when they both ship from pharmacies outside Canada? The rogue pharmacy has a much higher chance of causing you harm, especially if it doesn’t require a prescription, doesn’t send meds from licensed pharmacies, or lies about where your medication comes from. There’s no accountability. When ordering from PharmacyChecker-verified Canadian online pharmacies, you will be given the choice where your meds come from, you will know your medication is coming from a licensed pharmacy, and you will have to have a valid prescription.

PharmacyChecker.com verifies pharmacies in Australia, Barbados, Canada, India, Mauritius, New Zealand, Turkey, U.S., U.K, and Singapore. Pharmacies in Barbados, India, Mauritius, and Singapore undergo a rigorous inspection for safety and drug quality. You can read about our standards. Keep in mind, the medications at your local U.S. pharmacy come from literally dozens of countries, with most generics coming from India.

We contacted Mr. Rothstein to let him know that the Canadian online pharmacy industry is global to help him in his future coverage of issues relating to prescription drug importation, online pharmacies and affordability. We want you to find the safest medication at a price you can afford, but we also want you to know where it’s coming from. The PharmacyChecker.com seal on a website will let you know that you are working with a real pharmacy, no matter where your meds come from.

 

 

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On February 12th of this year, we sent a comprehensive report about buying medication online to the Senate Committee on Health, Education, Labor and Pensions and House Committee on Energy and Commerce. Our purpose was to correct the public record by challenging a flawed report about Internet pharmacies written by the Government Accountability Office (GAO) back in 2013. The GAO’s report essentially parroted the narrative that the pharmaceutical companies, U.S. pharmacies, and FDA want you to hear, which ignores the existence of safe international online pharmacies that help Americans afford safe medication. Due to the incredible importance of this issue, we are publishing a section of our report each week. For the full report, click Online Pharmacies, Personal Drug Importation and the Public Health.

This week you can read a “History of Online Pharmacies.” It’s not a comprehensive history but gives the reader enough background to digest the larger issues contained in the report. When you think about, online pharmacies are really “mail order pharmacies” with websites. Did you know that mail order pharmacy has been around for well over a hundred years?

The Internet has facilitated a major proliferation of mail-order pharmacy operations. Mail-order pharmacies are not new; they have served Americans since the late 1800s. Internet pharmacies, often referred to as “online pharmacies,” can be defined as websites that market and sell prescription medication over the Internet that is dispensed by mail-order. When they began operating in the mid to late 1990s, online pharmacies quickly became a subject of concern for federal regulators and Congress due to dangerous and illicit practices. The NABP created the Verified Internet Pharmacy Practice Sites (VIPPS) in 1999, a voluntary program open to domestic pharmacies to help consumers identify safe online pharmacies.

Drugstore.com, which launched its website in 1999, was considered a first-mover in the industry and an example of a safe online pharmacy without a bricks-and-mortar presence. It required a valid prescription and dispensed medication from a licensed pharmacy. By the beginning of the last decade, most major chain pharmacies were doing business online by taking new and refill prescription orders, and mailing them across the country. Drugstore.com and most but not all online pharmacies associated with major chain pharmacies and Pharmacy Benefit Management (PBM) companies became VIPPS-approved by 2003.

Around 2000, Canadian pharmacies began online marketing to reach American consumers, which provided Americans with access to low-priced drugs. Previously, personal drug importation from Canada was relegated to those living on border-states. This issue also gained public attention through media coverage of bus trips, which brought seniors up to Canada to buy medication and were sometimes sponsored by U.S. politicians supportive of reforming drug importation laws. Canadian pharmacies later began partnering with licensed pharmacies in other countries, such as Australia, New Zealand, and the UK, and later India and Turkey, as well as those in free trade zones. They did so in part to evade supply restrictions imposed by pharmaceutical companies against Canadian pharmacies, but also to take advantage of even lower drug prices found elsewhere and to increase profits.

In 2002, PharmacyChecker.com began operations to verify both U.S. and foreign online pharmacies – as well as to compare drug prices for consumers seeking the lowest prices for their medications. CIPA was founded that same year. CIPA’s vice president testified at a congressional hearing in 2003 entitled: “International Prescription Drug Parity: Are Americans Being Protected or Gouged?” In 2004, the FDA recognized PharmacyChecker.com’s efforts to help consumers find the lowest prices and directed people to www.pharmacychecker.com as part of media relations efforts to show that U.S. generic drug prices are lower in the U.S. than in Canada.

While the Internet has enabled millions of Americans to find safe and lower cost medication from outside the U.S., it has also created a public health minefield where dangerous websites posing as safe pharmacies, U.S. and foreign, are accessed every day. Such websites sell fake, adulterated and/or low quality medication, or genuine and safe prescription drugs but without requiring a prescription. These rogue online pharmacies are a serious threat to patient safety and have caused sickness and death.

While too many Americans today have online access to and buy from rogue foreign pharmacies, many are benefiting from safe foreign pharmacies. Americans, including elected officials and public health regulators, know that low-priced and safe prescription medication can be found online internationally. For instance, former Health and Human Services Secretary Kathleen Sebelius adopted a personal drug importation program when she was Governor of Kansas that allowed consumers to find international pharmacies over the Internet. The State of Maine recently updated its pharmacy licensure requirements to permit sales from pharmacies that are licensed in Australia, Canada, New Zealand and the United Kingdom, in effect abolishing state restrictions on personal drug imports from those countries.

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Continuing our 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 a section a week of our report called Online Pharmacies, Personal Drug Importation, and Public Health. The Government Accountability Office Report on Internet pharmacies, which we’ve attested contains inaccuracies and is misleading about buying medication online, clearly relied heavily on pharmaceutical industry sources. Here’s how:

Some pharmaceutical companies, including many members of the PhRMA, view foreign online pharmacies as a commercial threat because Americans are able to obtain medications at lower prices leading to lower profits. The U.S. pharmacy industry views non-U.S. online pharmacies as unfair competition because the latter can charge lower prices. Many of the groups identified by GAO as stakeholders are drug companies and U.S. pharmacies or groups that they fund, including the following groups:

  1. Alliance for Safe Online Pharmacies
  2. International AntiCounterfeiting Coalition
  3. National Association of Boards of Pharmacy Pharmacies
  4. National Association of Chain Drug Stores
  5. National Community Pharmacists Association
  6. Partnership for Safe Medicines
  7. Pharmaceutical Security Institute
  8. PhRMA

Of the 35 stakeholder groups identified by GAO, at least 33% (13) are pharmaceutical companies or groups that receive funding by pharmaceutical companies or U.S. pharmacies. Another stakeholder is the Center for Safe Internet Pharmacies (CSIP), as are eight of its member companies. CSIP is a private consortium of businesses formed in response to pressure by the White House Office of the Intellectual Property Enforcement Coordinator, which mostly operates as another voice and information clearinghouse for the other stakeholders listed. Three associations representing U.S. pharmacy boards and pharmacies are listed above.

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To see just how drug company lobbyists snake their way into the legislative process please read this next section, which follows the executive summary.

You can view the whole report here.

The GAO inquiry into online pharmacies mandated by FDASIA in its Section 1127 was drafted by a lobbyist in the employ of a government relations firm (FaegreBD Consulting) hired by the Alliance for Safe Online Pharmacies (ASOP), a group that is led by Eli Lilly, the National Association of Chain Drugstores and LegitScript.The executive director of ASOP is Libby Baney, who now runs a consulting firm called FWD Strategies International.1 According to its website, FWD Strategies International “is not just a name; it is what we do – moving your vision forward.” In marketing her firm, Ms. Baney notes that one of its services is drafting congressional legislation. As an example of draft legislation, she notes Section 1127 of FDASIA among others relating to online pharmacy.

As evidenced above, it’s not surprising that Section 1127 did not encourage the GAO to perform serious research and independent analysis about online pharmacy safety. Instead Section 1127 conspicuously calls for GAO to report on “laws, policies, and activities that would educate consumers about how to distinguish pharmacy Internet web sites that comply with Federal and State laws and established industry standards from those pharmacy Internet websites that do not comply with such laws and standards…” That language represents the “vision” of the founders and funders of ASOP, companies and people with a history of working to curtail access by Americans to lower cost medication from safe international online pharmacies.2


1 Libby Baney is identified as a lobbyist for the Alliance for Safe Online Pharmacies in this lobbying disclosure report: http://soprweb.senate.gov/index.cfm?event=getFilingDetails&filingID=6B1B406C-D5C0-48C6-9484-B9FF3B372B1F&filingTypeID=51 [Last accessed 10/21/2014].

2 Some of ASOP’s funders seek extreme actions, such as “delisting,” to achieve their goals. Eli Lilly recommends that search engines remove organic results so that Americans can no longer find online pharmacies that are not based in the U.S. See, testimony by Bruce Longbottom, JD, Eli Lilly, Statement to the House Energy and Commerce Committee, Subcommittee on Oversight and Investigations, February 27th, 2014, see http://docs.house.gov/meetings/IF/IF02/20140227/101804/HHRG-113-IF02-Wstate-LongbottomB-20140227.pdf [Last accessed 10/24/2014]. View the actual testimony about delisting here.

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Last week we wrote that we would present a new section of Gabe Levitt’s report on online pharmacies. This week, we are going to start off with the Executive Summary of the report. We’ve given a sample below, but you’ll have to visit PharmacyChecker.com to view the whole Executive Summary.

The U.S. government relies on the Government Accountability Office (GAO) for objective and independent research and analysis of government programs and policies that affect public health. GAO’s report entitled Internet Pharmacies: Federal Agencies and States Face Challenges Combatting Rogue Sites, Particularly Those Abroad (the “GAO report”) contains critical inaccuracies and omits important peer-reviewed research to the extent that lawmakers and their staffs will likely draw erroneous conclusions about international online pharmacies that could lead to overreaching and unnecessary enforcement actions that disadvantage consumers and threaten public health. The GAO report was written pursuant to Section 1127 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), a law dedicated to protecting public health.

In contrast to the GAO report, the following holistic, consumer-focused, evidence-based analysis discusses online pharmacies within the important context of a health crisis caused by high drug prices in America, and can more appropriately guide lawmakers on how to protect the public from counterfeit or substandard medication. Legitimate public health concerns about rogue online pharmacies are being used to encourage legislative, regulatory, and private sector actions that curtail online access to safe and affordable medication. The consequence of overreach could be millions more Americans facing economic hardship or having to forgo prescribed medication, which studies show can lead to more sickness and death.

Fifty million Americans did not fill a prescription due to cost in 2012, according to the Commonwealth Fund. According to the Harvard School of Public Health, over half of Americans who do not take prescription medication due to cost report becoming sicker.1 That means potentially 25 million Americans become sicker each year because they can’t afford prescribed medication. According to the U.S. Centers for Disease Control and Prevention (CDC), about five million Americans buy prescription drugs from foreign sources each year for reasons of cost.  Additional estimates show that between four and five million Americans get their imported prescription drugs through international online pharmacies due to their lower prices.
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Correcting the Public Record about Online Pharmacies and Personal Drug Importation

Correcting the Public Record about Online Pharmacies and Personal Drug Importation

In July of the 2013, the Government Accountability Office (GAO) published a report about Internet Pharmacies with a focus on foreign websites that I believe strongly distorted the public record about buying medication online through personal drug importation. GAO’s report was submitted to Congress in response to Section 1127 of the Food and Drug Administration Safety and Innovation Act, intended to protect the public health. I wrote a report to refute the GAO’s positions in order to correct the public record regarding the intersection of online pharmacies, personal drug importation, drug affordability and the public health. I believe that my report about online pharmacies proves that the GAO’s efforts fell very short in getting to the truth about buying medication online.

Americans buy lower cost and safe medication internationally, often online, and it benefits their health and financial well-being. If it were not for the option of personally importing lower cost medication, often using the Internet, many Americans would just not be able to get medical treatments they need. People who can’t take needed medication often get sick and may even die.  The GAO report did not mention these facts.

The GAO seemed to conflate safe international online pharmacies with rogue online pharmacies in the same manner we’ve come to expect from the pharmaceutical industry, U.S. pharmacy trade associations and the FDA – by calling safe international online pharmacies “rogue.” The problem, for me, is that its lead author is not with the pharmaceutical industry, a U.S. pharmacy trade association, or the FDA. She is someone I’ve come to admire over the years just by following her work with GAO. So I can’t just say “look, it’s big Pharma again!” So for almost a year and a half I’ve written a report to, in part, prove to and remind myself that “we’re right and they’re wrong.” I’ve done that. I look forward to this report becoming a part of the public record.

Rogue online pharmacies, meaning drug-selling websites that are not safe (see my report for details), should be shutdown. Let’s get rid of them! However, if our elected leaders and regulators allow or enact policies to bring about an end to online access by Americans to safe and affordable medication and people get hurt, then they can’t say they didn’t know.

Below, I’ve pasted the cover letter from Tod Cooperman, MD, president of PharmacyChecker.com, and I that accompanied the hardcopy of the report we sent the congressional committees that received the GAO’s report in 2013. Each week we’ll be commenting on and posting the different sections of my report. To read the report now, visit “Online Pharmacies, Personal Drug Importation and Public Health”.

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Some consumers who order medication from safe international pharmacies are finding themselves unable to use their VISA credit cards. We hope that doesn’t interfere with their ability to access safe and affordable medication. What’s going on?

Essentially, in taking actions to stop rogue online pharmacies from selling medication, VISA’s online pharmacy policy ends up discriminating against consumers seeking affordable medication from safe international online pharmacies. It appears that VISA has adopted the online pharmacy worldview of LegitScript, a verification service that categorizes safe international online pharmacies as “unapproved” (but not “rogue”) and teams up with big pharmaceutical companies and U.S. chain pharmacies!  VISA’s policy may set a precedent for more credit card payment processors; discontinued service to rogue pharmacy websites is good, but if service is discontinued to safe international online pharmacies, including ones approved by PharmacyChecker.com, that’s bad. (more…)

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Nexium OTC or Prescription Nexium: Singing the Generic Blues as Esomeprazole Magnesium Stays Purple

Last June we wrote about how Americans taking Nexium – AstraZeneca’s multibillion dollar proton pump inhibitor that treats gastro esophageal reflux disease (GERD) – were losing out on savings due to the FDA’s postponement of a generic version in the U.S. market. Well, it looks like they’re going to wait even longer to find generic copies of the Purple Pill at local pharmacies (and the generic versions probably won’t be purple!). Initially, Indian pharmaceutical company Ranbaxy held exclusive marketing approval to sell generic Nexium in the U.S., but they were banned from actually selling it due to poor manufacturing practices. Well, last week the FDA revoked both Ranbaxy’s approval and its marketing exclusivity for generic Nexium. That might be good for the Purple Pill’s profits (say it fast) – but it leaves consumers singing the blues.

Cash paying Americans are left with the following domestic options: Prescription-strength (40 mg), Nexium or Nexium OTC (20 mg). Prescription-strength Nexium will run you about $600 for 60 pills. That’s a ridiculous price. It’s only $70 to get 126 capsules of Nexium OTC! So, can you just buy Nexium OTC instead of prescription-strength Nexium and just take two pills?

You might be able to, but you need to ask your doctor, pharmacist, or other healthcare provider. I asked my local pharmacist if I could just take OTC Nexium instead, and without hesitation she said I could, but that it may not be as effective and that it comes as a tablet rather than a capsule. The OTC version also has different inactive ingredients, I was told, so if you are allergic to any of those, you should stick with the 40 mg version. She suggested OTC Nexium if I couldn’t make a trip to my doctor or if my insurance didn’t cover prescription Nexium. Even if Nexium is covered, it might be a tier 2 or 3 drug, which could result in your co-pay being higher than the OTC cost.

We’d feel remiss in not reminding you that there are a plethora of proton pump inhibitors on the U.S. market, many that come at a much lower price tag.

But if you need to stick with prescription-strength 40 mg Nexium, it is available from international online pharmacies: 60 pills would be about $50, so it’s actually a better deal than Nexium OTC in the U.S. It’s worth noting that just like the OTC 20 mg pill, the 40 mg purple pill is sold as a tablet, not a capsule, in many foreign markets. You can view our comparisons of Nexium prices.

Hopefully we see these delays sorted out, and a generic version of 40 mg Nexium finally come to market in America. Until then, Nexium OTC at your local drugstore or ordering from an international online pharmacy may be your best options to avoid the drug price blues.

 

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A Letter to the ICANN Community

Today, the Wall Street Journal reported on the subject s of rogue online pharmacies and the Internet Corporation for Assigned Names and Numbers (ICANN). The gist of the article is that ICANN is not doing enough to stop dangerous pharmacy websites. There is reason to believe that ICANN could do more but it could also do too much to the detriment of consumers who cannot afford medication locally. There’s an appropriate middle ground for getting rid of rogue pharmacy sites, but not overreaching and ending online access to safe and affordable medication. Willfully ending such access threatens the public health and treads on global norms relating to human rights and access to medications.

Earlier this month I attended an ICANN conference for the first time, which was in Los Angeles. We’ve written on several occasions about the application by the National Association of Boards of Pharmacy (NABP) to ICANN to operate a new generic top level domain (gTLD) called “.pharmacy”. To remind many of our readers, gTLDs are the endings of websites, such as .com, .org, .gov, .edu, .int, etc. The bottom line here is that we and many others believe that NABP, if its application is successful, will use its new ICANN-conferred legitimacy to stifle competition, mislead the public about online pharmacies, and in doing so curtail access by Americans and consumers worldwide to safe and affordable medication online.

I met many dedicated, interesting and well-informed people at the ICANN conference, including those serving within the ICANN community and others following it closely. To follow up with them I wrote the following letter.

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