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Low Cost Counterfeit Drugs Save Lives in China…What?!

I wish I was joking about the racy headline above. The United States is not the only great power in which citizens go without medication because of cost. The cancer drug Gleevec (imatinib), made by Novartis, costs 23,500 yuan, or about U.S. $3,783, per month, in China. Gleevec is not covered by health insurance in China so people there must pay for it out of pocket. Ten years ago, Lu Yong was diagnosed with chronic myelocytic leukemia and was prescribed Gleevec. After facing bankruptcy due to his drug costs, Lu discovered a generic version of Gleevec, called Veenat, and began purchasing it by mail-order from India where it is an approved drug, at a cost of only 3,000 yuan, or about $482, per month — 87% less than the brand name drug.

Lu’s condition improved quickly using  the generic version. He began to help people with leukemia who he met online obtain Veenat. Now, according to the English edition of Caixin, an independent Beijing-based media outlet, he is facing criminal charges for credit card fraud and selling counterfeit medication. The same story was covered by official Chinese media under the headline “Leukemia patient prosecuted for buying pills overseas.” Lu has helped 1,000 people with leukemia obtain treatment. Three hundred of them are petitioning the authorities to have his name cleared.

The medications involved are real and clearly life-saving! So why is Lu being prosecuted for counterfeit drugs? Under Chinese law, any drug not specifically licensed for sale in China, even a genuine medication lawfully manufactured by an authorized drug company, is considered counterfeit.

The charge of credit card fraud was based on Lu’s using a foreign credit card to make the purchases. Lu said he did so because using domestic Chinese bank-issued credit cards for international purchases is nearly impossible.

Lu was not charged for procuring his own cancer medication. The charges were for directly facilitating the purchase of the drug for 1000 people, who consequently regard Lu as a hero.

When people can’t afford to obtain life-saving medication locally, the U.S, and all countries, should consider themselves morally obligated to expressly permit their citizens to obtain it internationally.

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FDA Hunting Down Drug Counterfeiters and Online Pharmacy Bad Guys

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…)

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PharmacyChecker.com Statement on Wall Street Journal Investigative Report About Fake Avastin

For the last six months the WSJ has actively reported on fake Avastin purchased by some medical clinics in the United States. The latest report focuses on the fact that the owner of the foreign wholesaler that shipped the fake Avastin to the U.S. is also the owner of a large international online pharmacy called CanadaDrugs.com. The WSJ reporting makes it clear that the wholesale business is separate from CanadaDrugs.com.

CanadaDrugs.com is a long-standing member of the PharmacyChecker.com Verification Program. It takes orders online filled by licensed pharmacies that require a valid prescription. It does not sell Avastin and the WSJ didn’t report any safety problems associated with its operation.

PharmacyChecker.com’s programs are designed to provide information to consumers seeking safe and affordable medication online for their own use. We recognize that importation by medical clinics does occur and the reason is that drug prices of many drugs are unusually high in the United States. We believe that wholesale drug importation presents unique drug supply and safety challenges that should be addressed but are not related to personal drug importation.

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Fake Adderall Sold Online According to FDA, Warns Consumers

Consumers searching for Adderall online should use extreme caution. The FDA announced that it found fake Adderall, a drug for Attention Deficit Hyperactivity Disorder and Narcolepsy, is being sold online. Adderall is a controlled substance, a prescription drug with greater addictive potential and subject to strict regulatory controls. Reputable international online pharmacies, such as those approved in the PharmacyChecker.com Verification Program, do not sell this product or other controlled substances to Americans.

Sales of controlled substances online are governed by the Ryan Haight Online Pharmacy Consumer Protection Act, which expressly bans the sale to Americans of controlled substances online from pharmacies that are not registered with the U.S. Drug Enforcement Agency. The Act also prohibits pharmacies from dispensing controlled medication based only on a remote medical consultation, meaning the patient’s prescription must be the result of an initial physical exam. For more see PharmacyChecker.com: Controlled Substances and Online Pharmacies – Use Extreme Caution.

The FDA did not identify the websites that are selling the fake Adderall. According to the FDA, the fake Adderall contained Tramadol and acetaminophen, which is medication to treat pain. The FDA’s announcement also included pictures of authentic and fake Adderall.

Legitimate Adderall manufactured by Teva

Legitimate Adderall

Counterfeit Adderall discovered by the FDA

Counterfeit Adderall

Whether the problem is lack of supplies, which is a current problem for Adderall, or high costs, it is understandable that Americans are trying to find access online to needed medication that they cannot get at their local drugstores. But it’s critical to use common sense and only buy from credentialed online pharmacies. This will enable you to get most medications you need and protect yourself from falling victim to fake and dangerous drugs.

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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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