Drug Companies Front and Center at PSM Interchange Conference
Two weeks ago I brought you some highlights of the PhRMA-led Partnership for Safe Medicines (PSM) Interchange propaganda show, which was held on September 18th. Look over to the left. See that picture. Those logos of big pharmaceutical companies make it abundantly clear who is pushing the distorted message of PSM about personal drug importation and online pharmacies.
I’m not joking about the word “propaganda” applied to the PSM event. The online Merriam Webster dictionary provides the following definition for that word: “ideas or statements that are often false or exaggerated and that are spread in order to help a cause, a political leader, a government, etc.” In this case, as I see it, the “cause” of PSM is the commercial agenda of the pharmaceutical and U.S. pharmacy industries cynically couched behind terms of patient safety. A central message of PSM is that Americans are risking their lives buying medication online from other countries and that there is no way to do so safely. Those are false and exaggerated messages that are potentially leading lawmakers and regulators to overreact and scare Americans from a potential lifeline of affordable prescription drugs. Evidence shows that this has been PhRMA’s communications strategy for more than a decade. (more…)
Tagged with: Counterfeit Drugs, daniel burke, FDA, Interchnage, laganga, Mississippi AG hood, OCI, Partnership for Safe Medicines, phrma, PSM
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.
Tagged with: avastin, CanadaDrugs.com, Counterfeit Drugs, personal drug importation, Wall Street Journal
This Op-ed by our vice president, Gabriel Levitt, was first published in the popular Opinion/Controversy website – Opposing Views. We’re re-publishing the op-ed below.
Eleven years ago, an eighteen year old American named Ryan Haight tragically died from
an overdose of Vicodin, purchased online without a prescription. The Vicodin was real, not fake. In Niger, a much larger tragedy occurred – 2,500 people died out of 50,000 who were inoculated with bogus medication. The worst tragedy in recent U.S. history was the death of 238 Americans after ingesting fake Heparin found in the legal U.S. drug supply in 2007 and 2008. The Institute of Medicine reports that 100,000 Americans die each year due to prescription drug errors here in the USA.
What do all of these disparate and depressing statistics have in common? They have nothing to do with personal drug importation from properly credentialed online pharmacies. And yet opponents of safe importation insist that it is not safe, an assertion that runs contrary to the evidence.
A recent study published by the National Bureau of Economic Research, called “Unveiling
the Mystery of Online Pharmacies: an Audit Study,” shows that Americans who purchase
medicine from properly credentialed non-US online pharmacies receive genuine (not fake)
medication at much lower prices than U.S. pharmacies. In this study mystery purchases of
popular brand name drugs were tested for authenticity. All tested medications that were ordered from U.S. and non-U.S. websites approved by PharmacyChecker.com, National Association of Boards of Pharmacy, LegitScript.com, and the Canadian International Pharmacy Association were found to be authentic. Some non-credentialed website purchases failed testing.
A few weeks back Senator John McCain introduced an amendment to the Prescription Drug User Fee Act (PDUFA) to facilitate personal drug importation from credentialed Canadian online pharmacies. Unfortunately, while the larger bill passed, McCain’s amendment failed 54-43. Even worse, though removed from the Senate version by unanimous consent, the House version of PDUFA, which passed with overwhelming support, contains a section – 805 – that authorizes the Department of Homeland Security (DHS) to seize and destroy safely imported genuine medication valued at $2,000 or less. Since imported medication valued under $2,000 is for “personal use” the language was clearly aimed at destroying medication ordered internationally, often online, by individual Americans.
The putative goal of Section 805 is to protect Americans from counterfeit and dangerous drugs. In reality it will only hurt patients by blocking their ability to obtain affordable medication. Other parts of PDUFA contain forward thinking measures to protect us from counterfeit and substandard drugs, such as increasing penalties against drug counterfeiters, strengthening registration requirements on, and improving inspections of, foreign drug manufacturers. It also has provisions that could help bring needed pediatric medicines to market faster. But seizing and destroying safe personal imports will not help solve the counterfeit drug problem. Moreover, tens of millions of Americans don’t fill prescriptions each year due to the high cost of medication – 48 million in 2010 according to the Commonwealth Fund. Aggravating this public health crisis by destroying people’s prescription drug orders will result in more sickness, hospitalizations and death.
About a million Americans rely on safe non-US online pharmacies. If Section 805 is not
removed from PDUFA then DHS will seize and destroy safe prescription drug orders en
route to patients. That is medically unethical and a threat to public health. Section 805 must be removed from the final bill to avoid even more Americans going without needed medication.
First published here: http://www.opposingviews.com/i/health/conditions/eliminate-counterfeit-drugs-don-t-curb-access-safe-and-affordable-medication
Tagged with: avastin, Counterfeit Drugs, Gabriel Levitt, NBER, Opposing Views, PDUFA
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.
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.
Tagged with: Adderall, Counterfeit Drugs, FDA, pharmacychecker.com, Ryan Haight
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.
Tagged with: Bryan Liang, Counterfeit Drugs, Online Pharmacies, Online Pharmacy Verification Services, personal drug importation, Thomas Cubic
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