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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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Counterfeit Drug Bill Gets Tough on Criminals, Not Consumers

A bill was introduced in the House of Representatives last week that would make repeat counterfeit drug offenders subject to 20-year maximum jail-terms with $4 million fines for individuals and $10 million if the defendant is an entity. PharmacyChecker.com applauds the introduction of H.R.3468, Counterfeit Drug Penalty Act of 2011, as we believe, if passed, it will act as a deterrent against individuals and businesses who endanger the public health by manufacturing and selling medication that is not subject to government regulations and oversight at best, and deadly at worst.

We also recognize that the bill’s language is clear not to blur the distinction between counterfeit and safe imported medication. The bill states:

Nothing in this Act, or the amendments made by this Act, shall be construed to apply to a drug (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)) solely because the drug is manufactured in or imported from a foreign country.

In contrast,  the proposed  Stop Online Piracy Act and Protect IP Act, now before Congress, defines all personally imported medicine, including genuine medication as a threat to the “public health.” This should be opposed. This language appears based on the lobbying rhetoric of the pharmaceutical industry to confuse lawmakers and consumers into believing the false proposition that all personally imported medicine purchased through online pharmacies is counterfeit. Thus, it’s a positive development that H.R. 3468 is crystal clear about the difference between counterfeit and imported drugs.

Stopping drug counterfeiters, whether they infiltrate the domestic supply chain by selling products to U.S. pharmacies or export dangerous drugs ordered online directly to Americans, protects the public health. The Counterfeit Drug Penalty Act seems to go after the real bad guys while not interfering with access to safe and affordable imported medicine and we hope it passes soon.

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WHO Statistic on Online Counterfeit Drugs Often Misused

In speeches and writings about online pharmacies, many experts and professionals in the pharmaceutical and U.S. pharmacy industries cite data from the World Health Organization (WHO) claiming that 50% of drugs sold on the Internet are counterfeit. A recent example is an article published last week in US Pharmacist.  This statistic is often offered as “evidence” that all online pharmacies, particularly outside the U.S., are dangerous.  However, the WHO’s information is often misused and the statistic’s factual basis is questionable.

The actual WHO statistic is that in “50% of cases, medicines purchased over the Internet from illegal sites that conceal their physical address have been found to be counterfeit.” WHO goes onto qualify this statement, noting that “Some Internet pharmacies are legal operations, established to offer clients convenience and savings. They deliver medications from government-licensed facilities and sell only on the basis of a prescription.” This is a critical point which we have made many times on this blog, but is commonly omitted by those whose work is backed by the pharmaceutical and U.S. pharmacy industries. (more…)

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