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The Global Counterfeit Drug Problem and Safe International Online Pharmacies Are Not Related

On May 14th, an article appeared in ForeignAffairs.com called “Dangerous Doses: Fighting Fraud In The Global Medicine Supply Chain.” Authors Tim Mackey, Bryan Liang, and Tom Cubic simultaneously report on the counterfeit drug threats and tragedies experienced globally while deceptively attempting to link safe international online pharmacies to this problem. Our vice president, Gabriel Levitt responded in Telling the whole truth about online pharmacies. His response is published below.


Telling the whole truth about international online pharmacies

Over a decade of experience and empirical studies [See “Unveiling the Mystery of Online Pharmacies: an Audit Study” in National Bureau of Economic Research] have shown that credentialed international online pharmacies sell safe and affordable medication, not counterfeit drugs, to Americans who otherwise might cut back or not take their medications at all. These credentialed websites work with licensed pharmacies that require a prescription and meet high safety standards for mail-order pharmacy. They just happen not to be located in the United States, which explains their low prices. They are not a part of the counterfeit drug threat but the authors of this article would like you to think that they are

So why do these authors take this position? Although not well disclosed, the two senior authors are directly affiliated with pharmaceutical corporate interests. Pharmaceutical companies in the U.S. do not want their sales undercut by lower cost imports of the same exact medicines they sell here because it negatively affects their profits. No one disputes this. Bryan Liang maintains a leadership position with the Partnership for Safe Medicines (PSM), which is largely funded by pharmaceutical companies and is currently led by the Deputy VP of Public Relations for the Pharmaceutical Researchers and Manufacturers of America (PhRMA). Thomas Cubic is head of the Pharmaceutical Security Institute (PSI), an organization of pharmaceutical company members. I believe the two entities share an office in Virginia.

The pharmaceutical industry has focused a lot of its lobbying muscle against drug importation laws that could help millions of Americans obtain needed medication. The pharmaceutical industry position is advocated on many levels through Liang’s Partnership for Safe Medicines and Cubic’s PSI, as well as through PhRMA and the National Association of Boards of Pharmacy with the goal of preventing non-US online pharmacies from selling to Americans even if they are safe. A careful reader would certainly find their position in this article.

The authors here accurately acknowledge that a majority of the world’s counterfeit drugs and the subsequent sickness and death they cause are found in countries with weak drug regulations and/or enforcement of laws. But they try and equate huge tragedies in developing countries where counterfeit drugs kill hundreds of thousands with the real but different dangers posed by the Internet.

Let’s just make one thing clear: The counterfeit drug problems found through online pharmacies in the rich countries are real but miniscule compared to the tragedies reported about in poorer countries. In fact, examples provided in this article perfectly reflect the sharp dichotomy in the numbers of counterfeit drug victims in the United States and in poorer countries. Eleven years ago one young American named Ryan Haight, 18, tragically died from an overdose of pills purchased online, which he should have never received. But it’s worth noting that the drug, Vicodin, was real – not counterfeit. In this case, the problem was dispensing medications without proper medical supervision – not counterfeit drugs. The people who sold him the Vicodin went to jail. In Niger, a much larger tragedy occurred – 2,500 people died out of 50,000 who were inoculated with bogus medication. Of course this had nothing to do with U.S. drug importation or online pharmacies. One might have expected the authors to mention the 238 Americans who died after ingesting fake Heparin, which was circulating thorough the legal U.S. drug supply in 2007 and 2008. This, too, had nothing to do with online pharmacies but exceeds in victims any reported incidents having to do with the Internet.

The authors would like you to believe that CanadaDrugs.com, a credentialed international online pharmacy, is a part of the counterfeit drug problem so as to foster actions that could block access to such sites. They state that one of its suppliers is responsible for the counterfeit Avastin in the United States. They fail to mention, however that the counterfeit Avastin had nothing to do with online pharmacies, safe or otherwise. As it happens, many pharmacies in the United States have at one time or another unintentionally sold counterfeit medication – including CVS and Walgreens, which is not a reason to shut them down.

The source of the most recent large scale problem with intentionally sold substandard medications distributed in the United States is in fact GlaxoSmithKline. They were fined $750 million for intentionally distributing millions of substandard pills all across the country. These products were manufactured at their facility in Puerto Rico. U.S. Marshalls confiscated $2 billion of products from the plant in 2005, the largest such seizure in history and worth at least four times the value of all drugs imported by Americans from Canada each year.

There is no doubt that companies and people operating websites that purposefully sell fake drugs or even real drugs without a prescription need to be shut down, and in many cases criminally prosecuted. Victims of bogus online pharmacies certainly go underreported and the problem is very serious. But it’s a different problem from the large scale counterfeit operations that are killing hundreds of thousands of people in poorer countries – a crisis that demands immediate action to prevent the next massacre. The UNDOC may in fact be a better venue for international enforcement efforts, as the authors point out, because police actions may exceed the WHO’s mandate. Interpol’s enforcement work in Operation Pangea definitely took out a lot of bad guys – more such efforts are needed. Certainly working in concert, tapping their respective strengths, UNDOC, Interpol, WHO-IMPACT can bring us to a better place where the counterfeit drug threat goes on the decline.

But when it comes to the American pharmaceutical market, we find 48 million Americans not filling a prescription each year due to cost – an underreported crisis from which many die. Some of these Americans seek affordable and genuine medication online from Canada and other countries to acquire needed medication.

To directly address the core of Foreign Affairs readers, we must not allow our foreign policy and multilateral actions to disadvantage American consumers who are struggling or can’t afford prescription medication. So as we ramp up our efforts to stop criminals from infesting the world with fake drugs let’s not enact policies that will block the access of Americans to life saving medications simply because it improves our corporate balance sheets.

Gabriel Levitt

Vice President
PharmacyChecker.com

President
United Nations Association Brooklyn Chapter

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Online Pharmacy Economics: Extortion at Home, Freedom Abroad?

Americans need and deserve the freedom to buy medications that are safe and affordable. This is not only true as a matter of right and wrong; it’s a public health issue since about 48 million Americans don’t fill prescriptions due to cost. Online pharmacies offer an important outlet for affordable medication. That’s the good news. The bad news is that some Americans are forced to use online pharmacies when they would rather not; and others who need them are discouraged from doing so. What’s going on here?

According to a recent L.A. Times article, “Consumer Confidential: Fewer choices on buying medications,” more and more Americans are being forced by pharmacy benefit managers (PBMs) to purchase their medication through domestic online pharmacies. Traditionally, PBMs acted as middlemen between health insurance companies, drug companies, and pharmacies. The third party relationship between PBM and pharmacy is deteriorating and the online pharmacies being forced upon Americans are often owned and operated by the PBM! This stands in contrast to the international marketplace.

When it comes to buying medication from Canada and other international pharmacies, despite its technical illegality, Americans feel free to choose which online pharmacy they wish to shop from. We write “technically” because, due to its internal policy guidance on enforcement priorities, the FDA does not appear to prosecute individuals for buying foreign, non-controlled medication for their personal use. Still, the FDA discourages Americans from using all non-US online pharmacies, even safe ones.

Independent studies have shown that credentialed international online pharmacies can and do offer a safe shopping experience through which Americans can best afford their medication. This takes the wind out of the sails of safety-related arguments put forward by the pharmaceutical industry — which profits greatly from high American drug prices — against personal drug importation. But there are other criticisms of personal drug importation that have to do with economics.

Foreign pharmacies are cheaper because other governments negotiate with pharmaceutical companies to control drug prices for all their citizens, something the U.S. government does not do.  Thus, personal drug importation is criticized for “importing” drug price controls and spoiling our “free market” in pharmaceuticals. But is our pharmaceutical market truly free?

In the LA Times article mentioned above, Jerry Lacy, who played Humphrey Bogart in “Play it Again Sam,” commented on his actor union’s arrangement with one of the largest PBM’s, Medco, which serves over 65 million people. “It’s like extortion…you do it their way or they won’t pay.” Mr. Lacy drew this conclusion after discovering he could only fill his prescriptions at the pharmacy of his choice twice at the insured (lower) price but then would have to buy from Medco’s online pharmacy or pay full (a higher) price elsewhere.

A letter to the editor by Chief Medical Officer of Express Scripts, another PBM, called “Letters: What Drugs Cost, and Why,” claims that PBM’s do provide choices. Well, maybe somewhat; but this is only partially true because the individual’s choice is not preserved. The employer or insurer chooses the option – not the individual. William Hale, in another letter to the LA Times editor, writes that he had to buy 90-day supplies for his medication from his PBM, even though his doctor would often change medication or dosage before the end of the 90 day supply. As a result, he has hundreds of unused pills and has ended up spending more than he would have if his PBM allowed him to purchase 30-day supplies from his local pharmacy. [For an excellent analysis about the free market for companies but not consumers read: “Inside The Secret World of Drug Company Rebates.”]

With foreign governments negotiating for lower prices in order to reign in government budgets, pharmaceutical companies seek higher profits from higher drug prices in the American “not-so-free” market..The American pharmaceutical market victimizes the millions of American consumers who are forced each year to pay more and more than their foreign counterparts for the same brand name medication or suffer the health consequences due to not taking prescribed medication. One way Americans seek justice is through international online pharmacies.

If considering online personal drug importation or any online pharmacy, experts have advised consumers to avoid online pharmacies that are not credentialed by reputable third parties, such as PharmacyChecker.com or VIPPS. But using common sense, Americans can and do make wise decisions about buying drugs online. For generic drugs, U.S. online pharmacies are often less expensive than non-US online pharmacies. The complete opposite is true for brand name drugs. Due to price competition among international online pharmacies (and of course foreign price controls), Americans can acquire from abroad the same medications sold here at an 80% discount.

By herding more of their members to their own pharmacies obviously PBMs can offer lower prices than local pharmacies; but this price reduction is not due to a “free market.”  The only pharmaceutical market that is meaningful to most Americans is the one that provides them a safe prescription medication at the lowest price. Ironically it is often non-US online pharmacies that offer them such freedom.

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RxrRights.org Applauds Drug Reimportation Amendment Sponsored by McCain and Franken

In their blog yesterday, our friends at RxRights.org, an advocacy group dedicated to helping Americans afford needed prescription medication, applauded Senator McCain’s (R-AZ) amendment to the Food and Drug Administration Safety and Innovation Act to greater facilitate safe and legal personal drug importation of prescription medications from verified Canadian pharmacies. Despite Senator McCain’s emphasis on verification and product authenticity, and co-sponsor Al Franken’s (D-MN) statement on this bill’s role in reducing overall healthcare spending, the amendment failed in a 12-9 vote in the Senate Committee on Health, Education, and Labor and Pensions.

Those against the bill cited drug product safety issues and concerns over the anonymity of the internet. Most vociferously, Senator Barbara Mikulski (D-MD) claimed that even with the bill consumers would still not know where there drugs were coming from, failing to recognize or understand that the solution to this problem is written in the amendment, which calls for a verification process that would identify safe online pharmacies. Just such a program was adopted by Kathleen Sebelius, now Secretary of the Department of Health and Human Services, when she was Governor of Kansas.

For more on this vote, please visit RxRights.org.

Click here for a video of the committee hearing. Coverage of the amendment begins at 28:40.

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