McCain Amendment.

Senator John McCain (R-AZ) introduced an amendment to the Pharmaceutical Drug User Fee Act authorization bill that would create explicitly legal access to and facilitate safe and affordable medicine from Canadian pharmacies through a government list of online pharmacies. Sen. McCain should be applauded for continuing his efforts on this issue. Unfortunately, the amendment was voted down 43 to 54.

In his floor statements, predicting his amendment’s failure, Senator McCain communicated that too many of our elected representatives are beholden to the pharmaceutical industry. For that reason, we can expect future legislative actions to curb access to safe personal drug imports. Due to FDA’s current regulatory practices, Americans are not prevented from obtaining needed medications from verified international online pharmacies.


CBS News On Online Pharmacies and Drugs Safety

In a recent article, CBS News informs American consumers on critical issues of drug safety. When it comes to ordering prescription drugs online, especially from outside the United States, the article is clear that Americans should only shop from properly credentialed online pharmacies, such as those approved by PharmacyChecker.com.

Americans should take other precautions as well. For instance, you should only take prescription medications prescribed to you from your doctor. Check expiration dates to make sure your prescription product is still effective. Before taking medication, look at it closely for any indication something is not right, including disintegration or discoloration.


Online pharmacies discussed by world leaders at G8 summits

 Leaders from the world’s most advanced economies discussed online pharmacies at the recent G8 conference.  The topics discussed also included economic growth and development, food and nutrition, and international security. Global health experts criticized the G8’s agreement, as published in the Camp David Declaration, for an over-emphasis on intellectual property protection in its section that mentioned drug safety.

Americans who buy medication safely from properly credentialed international online pharmacies should be concerned about high level talks that address this issue. The pharmaceutical industry’s anti-consumerist positions on intellectual property rights are often overrepresented in such international organizations, and the industry seeks global action to shutdown safe international online pharmacies.

On the other hand, looking at the glass half-full, the Camp David Declaration makes clear that public safety – not intellectual property rights – are the goal in fighting rogue online pharmacies and counterfeit drugs:  “To protect public health and consumer safety, we also commit to exchange information on rogue internet pharmacy sites in accordance with national law and share best practices on combating counterfeit medical products.”

We strongly support international actions to thwart the sale of dangerous medications online to protect both American and global patients. In fact, PharmacyChecker.com has been dedicated for almost a decade to evaluating online pharmacies in order to provide information about those that sell safe and affordable medication.

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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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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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The main Op-Ed article in today’s New York Times, “The Wrong Way to Stop Fake Drugs,” calls for the legalization of personal drug importation from credentialed international online pharmacies, such as those approved in the PharmacyChecker.com Verification Program. Authored by Roger Bate, a resident scholar at American Enterprise Institute, the central message of the piece is that the technical ban on personal drug importation does not help the fight against counterfeit drugs but does discourage Americans from getting needed medication. We couldn’t agree more.

Dr. Bate offers evidence-based and compassionate approaches to help uninsured/underinsured Americans obtain medication at affordable prices and reduce the threat of counterfeit medication domestically and abroad. For more on this story see today’s press release

For the past year, Americans who buy medication from international online pharmacies have engaged through RxRights.org to help stop government actions that could block their online access to safe and affordable medication. Taking the cue from this latest op-ed, Americans should start asking their leaders to pass legislation directing the FDA to provide accurate information about online pharmacies. At the very least, the FDA should cease its categorical warning against all international online pharmacies for the simple reason that some are very safe and can help more Americans afford needed medications.

We looked at the top five brand name drugs by sales today to highlight the incredible price discrepancies between US pharmacy and international online pharmacy prices.

Price Comparisons for Lipitor, Advair Diskus, Nexium, Abilify, and Plavix

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Today we issued a press release showing that the most popular brand name asthma medications are on average 76% less when purchasing from the lowest-cost PharmacyChecker.com-verified online pharmacies than at U.S. bricks and mortar pharmacies. For example, a three month supply of Advair Diskus (250-50mcg/dose), a popular preventative medication, costs $947.97 at a bricks-and-mortar pharmacy in New York City. The same medicine, by the same manufacturer, costs $149.00, at a verified international online pharmacy – a savings of 84%. With such high prices domestically it’s no surprise Americans with asthma often find themselves going without needed treatments and ending up in emergency rooms.

A 2005 study sponsored by Kaiser Family Foundation, Harvard School of Public Health, and USA Today found that 44% of American households with an asthma sufferer are unable to follow prescribed treatments due to cost. According to the U.S. Centers for Disease Control and Prevention, 1.7 million Americans went to emergency rooms in 2009 due to their asthma conditions. The CDC attributed such hospitalizations to low adherence to asthma management strategies, which include taking preventative asthma medication. A study in the Journal of the American Medical Association last month reported that out-of-pocket costs for medicine were a factor in greater hospitalization rates among children with asthma in the U.S

The health benefits of products such as Advair Diskus, Flovent, and Singulair – preventative asthma medications –are sometimes difficult for patients to ascertain when they are not showing asthma symptoms. Unfortunately, because prices for these products are so high in the United States, Americans view skipping these medications as a way to save money and others simply can’t afford them. If more Americans could find these products at more reasonable prices, such as from verified international online pharmacies, then adherence would improve, leading to less ER visits, better overall health outcomes, and lower healthcare costs for all of us. And with more affordable asthma medication, trips to the grocery store will be less daunting.

For more on asthma medication prices, see the press release.

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As reported in DigitalJournal this past Wednesday, at a press conference in Keene, NH, Congressman Ron Paul (TX-14), Republican candidate for president, accused the pharmaceutical industry and the FDA of being in “bed together.” He derided their arrangement, characterized by a revolving door of people repeatedly switching jobs back and forth between the FDA and pharmaceutical industry, as collusion to reduce competition in the pharmaceutical marketplace, resulting in higher drug prices. When it comes to online pharmacies, personal drug importation and drug prices, Congressman Paul’s critique resonates all too loudly.

The pharmaceutical industry, through their main trade association Pharmaceutical Researchers and Manufacturers of America (PhRMA) has lobbied vigorously to keep safe personal drug importation illegal, and to scare Americans away through its media relations juggernaut and funding of the Partnership for Safe Medicine from buying safe and affordable medication online from Canada and other countries. PhRMA even commissioned the publication of a novel about a terrorist conspiracy – The Karasik Conspiracy in which terrorists attack Americans with bad drugs sold from Canada! This effort backfired and they pulled the plug on the publishing company, which then went ahead and published a different version of The Karasik Conspiracy novel in which a pharmaceutical giant poisons medications to protect its profits. (more…)

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Medicare Part D Is Not Enough For Many Seniors Suggests IMS Study

Some pharmaceutical industry folks, and their political allies, like to make the point that our nation’s seniors no longer need access to lower cost foreign medication because they now have new and improved Medicare drug plans. But a new report by IMS indicates that drug costs are having a negative effect on public health, including for our seniors’. Put simply, the data indicates that even with the improvements and savings offered by Part D of Medicare (Medicare’s drug benefit), seniors still struggle to afford the drugs they need.

According to the report, medicine use by 65 year olds decreased 3.1% — the largest decrease in any age group. As reported in the New York Times, Michael Kleinrock, director of research development at the IMS Institute for Health Informatics, a group that consults for the drug industry, said that seniors appear to be “rationing their care as they struggled to pay rising bills on fixed incomes.” Mr. Kleinrock also said, “We’re reaching a tipping point where patients will actually take that increased cost and use less medicine.” Leigh Purvis, who studies drug prices for the AARP explains that the drugs most often cut are those “where you don’t necessarily develop symptoms when you stop taking them.”

Greatest Prescription Decline for Adults 65 +

Source: IMS Health, LifeLink, Dec 2011; U.S. Census Bureau

Such cutbacks in drug utilization for needed medication are known to lead to increased emergency room visits and greater social costs. Indeed, according to the IMS data, emergency room visits are up by 7.4%. Other studies, such as one by the Commonwealth Fund, have shown that medication nonadherence (skipping your prescribed medication) have been linked to increased emergency room visits, hospital stays, and nursing home admissions. The new IMS report illustrates this correlation as it finds seniors cutting back on needed medication.

Some improvements to Part D of Medicare have already been implemented and the IMS data shows a $1.8 billion decrease in out of pocket spending on prescription medication that is likely due to these improvements.  More improvements are on the way as long as the Affordable Care Act is not overturned. However, it’s clear that our seniors continue to suffer negative health consequence because of drug affordability problems.

A recent survey by RxRights.org, a non-profit group advocating for Americans who purchase medication from Canada and other countries, shows that just over half of people who personally import medication through online pharmacies are in Medicare. So even with Part D available to them, they actively seek lower drug prices outside the United States, making it abundantly clear that seniors continue to need the option to personally import prescription medication. It is important that they do so safely, using pharmacies approved by third-party verification programs such as PharmacyChecker.com.

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A new study published by the National Bureau of Economic Research finds that pharmacies approved in the PharmacyChecker.com Verification Program sell safe medication and can help Americans achieve substantial savings. By filling 370 prescriptions through 41 online pharmacies and testing the authenticity of the medications received, independent researchers from the American Enterprise Institute in Washington, D.C. found no test failures among online pharmacies verified by third-party verifiers, such as PharmacyChecker.com.

Since all online pharmacies approved by PharmacyChecker.com – whether American or foreign – are licensed, require a prescription, and meet high standards of online pharmacy safety, the results of this study are not the least bit surprising. Past studies have shown the exact same results. Still, the FDA ignores the facts and continues a consumer education policy recommending that Americans completely avoid non-US online pharmacies. We believe the FDA’s policy is unethical and unfair.  More importantly, its policy is bad for the public health because less access to  affordable prescription drugs means fewer Americans will procure needed medications.

For more on this study see our news release.

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The New Healthcare Law Is No Panacea For The Drug Affordability Crisis In America

There is a drug affordability crisis in America. As we’ve reported, in 2010 48 million adults did not fill a prescription due to high drug costs. Perhaps surprisingly, in addition to millions of uninsured Americans, many Americans with insurance forgo prescription medication due to cost. Such insured Americans, unable to cover necessary medical costs, including medication, are often referred to as the underinsured. A previous study from 2004 by the American Society of Health-System Pharmacists reveals that 82.1% of those who restricted medication to due costs were actually insured. The picture is clear; underinsurance is a major issue in the battle to afford prescribed medication.

The Affordable Healthcare For America Act will help millions of Americans, including with their drug bills – but it is not a cure-all. It is uncertain how the new regulations will affect drug pricing. With drug price negotiations and cost reducing drug importation measures excluded from the healthcare act, and with millions of insured Americans currently struggling to pay high drug costs, what is to say newly insured people will not struggle to afford or go without prescribed medications?

Throughout the year PharmacyCheckerBlog will be following the research and predictions about drug affordability under the new law. Stay tuned…

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