A report on drug safety published today by the Institute of Medicine (IOM) identifies important threats to the public health from falsified and substandard drugs but seems to ignore the facts about online pharmacy safety and savings. IOM’s report, “Countering the Problems of Falsified and Substandard Drugs,” which is funded by the FDA, wrongly concludes: “Trustworthy, accredited online drug stores do not sell medicine more cheaply than any other registered pharmacy would. Steep online discounts attract customers, but come from illegitimate vendors.” This conclusion is contradicted by a study in the References section of IOM’s report. That study is called “Unveiling the Mystery of Online Pharmacies: An Audit Study” and it’s published by the National Bureau of Economic Research (NBER). The NBER study is clear that Americans achieve safety and huge savings when buying genuine medication ordered online from registered non-U.S. pharmacies approved by PharmacyChecker.com. Therefore, trustworthy online pharmacies, in fact, do offer much lower drug prices; they are, however, not based in the United States.
As we see it, the IOM’s report reflects the position of its funding source, the FDA, when it comes to online pharmacies. We believe that the FDA essentially allows but prefers to ignore safe personal drug importation in its consumer awareness campaigns. Tens of millions of Americans forgo taking medication each year due to high domestic prescription costs, according to the Commonwealth Fund. It’s common sense that discouraging consumers from buying more affordable and safe medication online just because the pharmacy is outside the country will lead to fewer Americans getting the medications they need. That’s because, as a CVS/Caremark study shows, high medication costs are the number one reason Americans skip their meds.
Like the FDA, the IOM report recommends that Americans only use online pharmacies approved by the National Association of Boards of Pharmacy’s Verified Internet Pharmacy Practice Sites (VIPPS) program. The main safety criteria for a VIPPS-approved online pharmacy are that its dispensing pharmacies are licensed, inspected by their governing regulatory authorities, and require prescriptions. PharmacyChecker.com-approved online pharmacies meet those standards, which are verified for U.S. or qualified foreign pharmacies. VIPPS-approved online pharmacies cannot help Americans afford needed prescribed medication on many brand name drugs because their prices are much higher than licensed non-U.S. pharmacies. Furthermore, the NABP’s Internet pharmacy programs receive funding from pharmaceutical companies, such as Pfizer, who don’t want Americans buying their medication at lower foreign prices, which could make one question NABP’s independence…
Tagged with: Drug Safety Report, Institute of Medicine, NBER
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