Yesterday, in the New York Times, Andrew Pollack reported on the swelling chorus of groups, politicians, and consumers who are sickened by the price of cancer drugs and medication costs generally. They are calling for pharmaceutical companies to justify the outrageous costs of medication.

As part of this swell of frustration and anger about drug prices, over 100 oncologists are calling for the U.S. government to take concrete steps to bring down the prices on expensive cancer medications, many which cost over $100,000/year. One of those steps is allowing importation of cancer drugs across borders for personal use. (What a novel idea!). Despite the federal restrictions on the practice, five million Americans already import prescription drugs across borders for personal use because the costs of medicine are too high domestically. The imports help people afford medications that they would otherwise go without. While people are not prosecuted for doing so as long as the imports are for personal use, expressly legalizing safe prescription importation from licensed pharmacies in other countries is a great idea for all medications, not just cancer medications, and would probably cause medication prices to fall at U.S. pharmacies.

Personal drug importation is just one step among several that doctors are calling on to improve access to affordable cancer medication. Others include allowing Medicare to negotiate drug prices like the Veteran’s Administration does; banning deals (“pay-to-delay”) between brand and generic drug companies, in which the former pays off the latter to postpone introducing a lower cost generic drug; and reigning in patent terms so that lower cost generics can come to market faster.

In reading the New York Times article, the tone of criticism reported on was veering toward visceral disgust that so many seem to have with the pharmaceutical industry. But the Wall Street Journal was on this issue, too. In “Doctors Object to High Cancer Drug Prices,” Jeanne Whalen writes: “The doctors focus attention on the financial burden to patients, saying the out-of-pocket costs are bankrupting many just as they’re fighting a deadly illness.”

To conclude, recall that last month we brought you a real story of an American family facing financial ruin due to the cost of a cancer medication. Lisa wrote:

“We are going broke, will probably lose our home and my husband will probably never be able to retire (even though his body is breaking down from 40+ years of a very physical job as a pipe fitter. I (the wife), am permanently disabled. We will die homeless before this drug ever comes within an affordable price.

“Why doesn’t anyone bring this to the press? Why does Congress and Obamacare turn a blind eye? How many hundreds have to die before this drug and options are researched.”

The media coverage mentioned in this post shows that people are bringing this to the press. It’s exactly the press coverage that Lisa and her family deserve, not to mention the tens of millions of Americans who don’t fill prescriptions each year because of cost! Now will the government do something or are they too under the yoke of the pharmaceutical industry lobbying juggernaut?

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A story last Friday on ABC News’s 20/20 featured the topic of counterfeit drugs, their dangers and where they’re being sold. The story was helpful in educating the public about the threat of counterfeit drugs but it really seemed to play along with a misleading narrative, one propagated by the drug companies, that foreign medications are the same as counterfeit drugs. I’ve debunked this nonsense before: affordable and safe medications sold from foreign pharmacies are not the same as counterfeit drugs. 

Also, as part of its feature on counterfeits, ABC’s website has a section called “How to Order Prescription Drugs Safely Online” that looks to the Alliance for Safe Online Pharmacies (ASOP) for useful consumer information.  ASOP is financed and operated by big corporate pharmaceutical interests that oppose personal drug importation from safe online pharmacies. If you have great health insurance that covers all of your medications, or lots of money to cover exceedingly high out of pocket prescription drug costs, then the recommendations of ASOP might work for you because they recommend big U.S. chain pharmacies, such as Walgreens and CVS, which charge the world’s highest prices for medication. Many other Americans actually NEED safe international online pharmacies, which ASOP would call unapproved or even “rogue.”

It its story, ABC investigative journalists tracked down people selling prescription medications on the street, from push carts, even in clothing stores – usually in relatively poor neighborhoods. Eventually those people were arrested, all for the viewing audience to see. According to the federal agents involved, some of the medications seized were counterfeit and people did not have to provide a prescription to buy prescription drugs. The story was very troubling. Indeed, it was a powerful indictment of our society, one in which drug prices are so outrageously high that people, such as undocumented immigrants without health insurance, look to street peddlers to find affordable medication.

ABC also covered what are known as “Storefront” pharmacies, which are located throughout the country, often in strip malls, where people go to buy medications from pharmacies in other countries by mail order. These storefronts usually have titles that include the words “Canada,” or “Canadian,” and “Drugs,” “meds,” “medicine,” “Rx,” etc., which indicate that a person can acquire medicine from Canada. ABC wanted to highlight that the medications ordered at these places often do not come from Canadian pharmacies but from other countries. ABC’s implication is that people are being misled. On the other hand, when watching the show, it appeared that storefront personnel did communicate that the orders would not come from Canada so I’m not clear on what’s going on here. We wrote a piece about online pharmacies related to this issue: “So You Want to Buy Cheap Medicine from an Actual Canadian Pharmacy. Here’s the Deal.”

We do not verify storefronts but we believe that some of them are essentially people and companies that help Americans place prescription drug orders from foreign pharmacies that require a valid prescription. In fact, through ABC’s mystery shopping (meaning purchasing prescription drugs from storefronts) they were required to submit valid prescriptions and did so. A few weeks later the journalists received four medications, two of them brand, Viagra and Zocor, coming from Singapore and the UK, and two generics, tadalafil (the brand version known as Cialis) and finasteride (the brand version known as Propecia), both Indian drug products.

The story made it seem as if the two generics were either substandard or counterfeit, as it was noted they contained “impurities” or “unknown ingredients”. What ABC News did not communicate is that the so-called “impurities” or “unknown ingredients” might be acceptable inactive ingredients, excipients, etc., just different from those in the brand versions sold in the U.S. This is normal: generic drugs in the U.S. often have different inactive ingredients from their brand name counterparts. When the Indian generics were chemically tested, ABC showed the results as “fail” but didn’t tell you that generics sold in U.S. pharmacies would likely have failed as well if given that same test because they are not the exact same as the brand in terms of inactive ingredients.

Also, when ABC reported that most of the medicines did not meet FDA standards, it didn’t explain that simply having a label designed for a different country automatically means it does not meet FDA standards, regardless of the medication’s actual safety. In short, foreign sourced medications are often safe and effective products, approved for sale in the countries from which they are dispensed – but not counterfeit or substandard.

It’s important to note that the generics received by the journalists came from India, and, as we’ve written about before, India does have more problems with low quality and counterfeit drugs than in the U.S. or other rich countries. At the same time, India is the largest source of generic medications, exporting across the globe to wealthy, middle income and poor countries. In fact, 40% of generics sold in U.S. pharmacies are from India.  It’s well known that the top Indian drug companies excel at making high quality, safe and effective prescription medications, but even among them problems exist, too.

On a closing note about ABC’s coverage of counterfeit drugs, I encourage our readers to look at the consumer comments section on ABC’s website.  People don’t believe the big drug company propaganda, or even our trusted regulatory authorities like the FDA. That bothers me because the FDA is right that there are rogue pharmacy operators out there, often online, but they’re wrong not to acknowledge the relative safety and public health benefits of safe international online pharmacies. Hopefully ABC will really investigate

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Is it legal to order medications online? Yes. If you live in the U.S., you can legally order medications online for mail order, such as from Walgreens or CVS. Is it legal to order medications from an online pharmacy located in a foreign country – to personally import it? Technically, no; but people who import small quantities of prescription medication for their own use, according to the FDA, are not prosecuted for doing so. There are a lot of nuances and quirky details when it comes to laws and regulations that apply to online pharmacies. Some laws are there to protect your health and safety; others seem more bent on protecting the profits of big drug companies – and there’s a lot in between. It’s complicated.

So this week, in our continuing quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing the next section of our report called Online Pharmacies, Personal Drug Importation, and Public Health

(more…)

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What does the data actually show about the safety of buying medication online? Is it really dangerous to buy lower cost medication from a pharmacy in another country over the Internet? Do drug companies fund research in this area?

This week, in our continuing quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing the next section of our report called Online Pharmacies, Personal Drug Importation, and Public Health(more…)

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Americans have been ordering medication over the Internet from foreign pharmacies for about 15 years. How many reported deaths or serious adverse reactions would you guess have been associated with purchases from international online pharmacies that require a prescription? Zero. Sadly, rogue online pharmacies, domestic and foreign, have contributed to injury and even death.

This week, in our continuing quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing the next section of our report called Online Pharmacies, Personal Drug Importation, and Public Health(more…)

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Continuing our quest to get the truth out and for our elected leaders in Congress to take bold action to protect online access to safe and affordable medication, we’re publishing a section a week of our report called Online Pharmacies, Personal Drug Importation, and Public Health. This week we look at the reasons why Americans look online to buy medication:

High U.S. drug prices are one of the main reasons that Americans go online to buy medication. As stated previously, according to the CDC, about five million Americans buy medication internationally each year due to high domestic drug prices. The CDC’s figures and others identified below show that over the past 15 years, tens of millions of Americans have purchased medication from outside the U.S. using online pharmacies to save money or because they could not afford the prices at their local pharmacies. Fifty million Americans between the ages of 18 to 64 did not fill a prescription in 2012 due to cost, up from 29 million in 2001. The data demonstrates that Americans need international online pharmacies due to a public health crisis of high domestic drug prices.

There are other reasons Americans go online to buy medication besides cost. Online pharmacies offer convenience and anonymity. For some consumers with mobility problems or for those who live in rural locations, ordering online and receiving medication by mail can be very helpful. Others may feel embarrassed about their medical conditions, which are sometimes unintentionally disclosed at their local pharmacy counters, preferring to order privately online.

Unfortunately, some Americans go online seeking medication without first obtaining a prescription from their healthcare providers. Many such people should not be judged. Americans who are uninsured may be unable to afford the medical care necessary to get a prescription and shop from online pharmacies that do not require one. Others just don’t want the “hassle” of going to the doctor and getting a prescription. There are obvious and inherent dangers in taking certain medications without first consulting with a licensed prescriber. Additionally, online pharmacies, foreign and domestic, that do not require a prescription are more likely to sell falsified and substandard medication and not ship medication safely.

Growing numbers of insured Americans in the coming years, a result of the Patient Protection and Affordable Care Act, will lead to a decline in medications ordered online without a prescription. However, many newly insured will find that their prescribed medications are not covered by their plans and are too expensive to pay for out-of-pocket at a U.S. pharmacy. For some, international online pharmacies are the only route to obtaining needed medication.

Finally, some Americans looking to obtain prescription narcotics without a prescription turn to the Internet, but the prevalence of such purchases are a small part of America’s prescription abuse problem. Still, the most serious negative health consequences related to prescription drugs bought over the Internet are from controlled drugs purchased without a valid prescription. The Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which largely banned online prescribing for controlled substances, was named after 18 year-old Ryan Haight who purchased prescription narcotics from an online pharmacy based in Oklahoma without a valid prescription and died from an overdose.

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When a Canadian Online Pharmacy Isn’t Just Canadian

An article by Joe Rothstein in EIN News concerning personal drug importation and online pharmacies recently caught our eye for two reasons. First, Mr. Rothstein called out the pharmaceutical industry for funding groups that give poor advice to consumers about buying medication online. Second, Mr. Rothstein identified PharmacyChecker.com as a source for “providing a list of certified Canadian suppliers who sell at prices usually well below the cost of U.S. pharmacies.” It is true that we do that, but our efforts extend far beyond Canada; we also verify and inspect pharmacies in many other countries, which was not mentioned in the article.

So what’s the issue? Remember, that according to the FDA, personally importing medication under most circumstances is technically illegal. Of course, many of us believe that it can be and is done very safely. Mr. Rothstein’s article states “…defenders of the importation law argue that thousands of phony online sites claim to be ‘Canadian’ to fool the unwary, and for self-protection consumers should avoid Canadian sites entirely.” Opponents of personal drug importation use those quotes around Canadian because they believe that dangerous rogue online pharmacies deceive consumers by claiming to be Canadian, only to ship medication from another country. On this count we agree with Big Pharma, however there are also safe Canadian online pharmacies that do refer prescription orders to licensed pharmacies in other countries. (more…)

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On February 12th of this year, we sent a comprehensive report about buying medication online to the Senate Committee on Health, Education, Labor and Pensions and House Committee on Energy and Commerce. Our purpose was to correct the public record by challenging a flawed report about Internet pharmacies written by the Government Accountability Office (GAO) back in 2013. The GAO’s report essentially parroted the narrative that the pharmaceutical companies, U.S. pharmacies, and FDA want you to hear, which ignores the existence of safe international online pharmacies that help Americans afford safe medication. Due to the incredible importance of this issue, we are publishing a section of our report each week. For the full report, click Online Pharmacies, Personal Drug Importation and the Public Health.

This week you can read a “History of Online Pharmacies.” It’s not a comprehensive history but gives the reader enough background to digest the larger issues contained in the report. When you think about, online pharmacies are really “mail order pharmacies” with websites. Did you know that mail order pharmacy has been around for well over a hundred years?

The Internet has facilitated a major proliferation of mail-order pharmacy operations. Mail-order pharmacies are not new; they have served Americans since the late 1800s. Internet pharmacies, often referred to as “online pharmacies,” can be defined as websites that market and sell prescription medication over the Internet that is dispensed by mail-order. When they began operating in the mid to late 1990s, online pharmacies quickly became a subject of concern for federal regulators and Congress due to dangerous and illicit practices. The NABP created the Verified Internet Pharmacy Practice Sites (VIPPS) in 1999, a voluntary program open to domestic pharmacies to help consumers identify safe online pharmacies.

Drugstore.com, which launched its website in 1999, was considered a first-mover in the industry and an example of a safe online pharmacy without a bricks-and-mortar presence. It required a valid prescription and dispensed medication from a licensed pharmacy. By the beginning of the last decade, most major chain pharmacies were doing business online by taking new and refill prescription orders, and mailing them across the country. Drugstore.com and most but not all online pharmacies associated with major chain pharmacies and Pharmacy Benefit Management (PBM) companies became VIPPS-approved by 2003.

Around 2000, Canadian pharmacies began online marketing to reach American consumers, which provided Americans with access to low-priced drugs. Previously, personal drug importation from Canada was relegated to those living on border-states. This issue also gained public attention through media coverage of bus trips, which brought seniors up to Canada to buy medication and were sometimes sponsored by U.S. politicians supportive of reforming drug importation laws. Canadian pharmacies later began partnering with licensed pharmacies in other countries, such as Australia, New Zealand, and the UK, and later India and Turkey, as well as those in free trade zones. They did so in part to evade supply restrictions imposed by pharmaceutical companies against Canadian pharmacies, but also to take advantage of even lower drug prices found elsewhere and to increase profits.

In 2002, PharmacyChecker.com began operations to verify both U.S. and foreign online pharmacies – as well as to compare drug prices for consumers seeking the lowest prices for their medications. CIPA was founded that same year. CIPA’s vice president testified at a congressional hearing in 2003 entitled: “International Prescription Drug Parity: Are Americans Being Protected or Gouged?” In 2004, the FDA recognized PharmacyChecker.com’s efforts to help consumers find the lowest prices and directed people to www.pharmacychecker.com as part of media relations efforts to show that U.S. generic drug prices are lower in the U.S. than in Canada.

While the Internet has enabled millions of Americans to find safe and lower cost medication from outside the U.S., it has also created a public health minefield where dangerous websites posing as safe pharmacies, U.S. and foreign, are accessed every day. Such websites sell fake, adulterated and/or low quality medication, or genuine and safe prescription drugs but without requiring a prescription. These rogue online pharmacies are a serious threat to patient safety and have caused sickness and death.

While too many Americans today have online access to and buy from rogue foreign pharmacies, many are benefiting from safe foreign pharmacies. Americans, including elected officials and public health regulators, know that low-priced and safe prescription medication can be found online internationally. For instance, former Health and Human Services Secretary Kathleen Sebelius adopted a personal drug importation program when she was Governor of Kansas that allowed consumers to find international pharmacies over the Internet. The State of Maine recently updated its pharmacy licensure requirements to permit sales from pharmacies that are licensed in Australia, Canada, New Zealand and the United Kingdom, in effect abolishing state restrictions on personal drug imports from those countries.

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Unfortunately, a Maine state law that was created to help people access lower cost medication from licensed pharmacies in Australia, Canada, New Zealand and the United Kingdom, was invalidated yesterday in a decision by federal court Judge Nancy Torresen. Basically the judge, invoking a legal doctrine called “preemption,” concluded that federal law beats state law when it comes to foreign commerce, and since federal law technically bans personal drug importation under most circumstances, Maine’s law is trumped. I’ll return at the end to deal with a little legalese fun (but not too much!).

Taking a walk down memory lane here: personal drug importation programs in Maine, such as one operated for the City of Portland, Portland Meds since 2004, which has helped Americans save many millions of dollars, were shut down in 2012 by former State Attorney General William Schneider. The programs were shut down because Maine’s pharmacy groups persuaded AG Schneider that Canadian and all foreign pharmacies should be stopped from mail order pharmacy sales into Maine because they are not licensed in Maine. Most U.S. states require pharmacies based elsewhere to obtain an out-of-state pharmacy license if they want to sell medication by mail to their residents. While there are exceptions, most states do not allow pharmacies in other countries to obtain an out-of-state license.

Maine legislators were angered by this action and passed a law, LD 171 “An Act To Facilitate the Personal Importation of Prescription Drugs from International Mail Order Prescription Pharmacies,” that exempted licensed pharmacies in Australia, Canada, New Zealand, and the UK from having to obtain an out-of-state Maine pharmacy license. Not only was this law passed on a bi-partisan basis but the vote was overwhelming: Maine’s House voted 107-37: the Senate voted 30-4. And with that the personal drug importation programs resumed.

The law was invalidated, now what?

Programs like Portland Meds will not necessarily shutdown. We’ll have to wait and see what happens. But if they do shutdown then thousands of Mainers will be paying more for their medications. More seriously, some Mainers will likely end up skipping their medications because the prices at their local pharmacies are too high for them. Back in 2012, an owner of one company that worked with CanaRx, a Canadian pharmacy benefit company, admitted that by working with licensed foreign pharmacies his company saved money: but there was more to the story than simply a company saving money. Quoting a journalist from the Bangor Daily News:

While acknowledging that Hardwood Products “as a company is trying to save money,” Young said his greatest fear is that a spike in costs will spur his employees to stop taking medications for conditions such as diabetes and asthma.

“We have many people here who are hourly employees,” he said. “We pay a fair wage, but the impact out of the family net income will be significant. More important than the money is the health and well being of the employees and their families. What dollar figure do you put on that?”

…but all hope is not even close to lost! Americans still have access to safe and more affordable medication available online, and, again, Maine’s programs have not yet shut down. Equally as important to the longer term cause of prescription justice, the ruling leaves the door open for the State of Maine to appeal the decision up the legal food chain to the 1st Circuit Court of Appeals in Boston. If Maine wins then other states may follow its lead by passing similar legislation to promote access to lower costs medications from other countries.

I’m pretty certain that, with the requisite political will from Maine’s legislators, citizen rabblerousing, and some good legal marksmanship, there are ways to overcome and defeat Judge Torresen’s ruling.

To conclude, I’d like to challenge something Judge Torresen opined in her ruling to nullify Maine’s foreign pharmacy law:

“Congress enacted the FDCA [Food, Drug and Cosmetics Act] to bolster consumer protection against harmful products.”…In furtherance of this purpose, Congress has created a complex regulatory scheme covering the importation of pharmaceuticals into the United States…

Is that so? Maybe…in part. However, I believe that banning Americans from importing lower cost and safe prescription medication from licensed pharmacies for their own use does nothing to bolster consumer protection against harmful products but quite a lot to bolster protection of big drug company and U.S. chain pharmacy profits. I know that the ban impedes Americans from taking medications they need and forces more financial hardship. Are these facts that could hold up in court? I think so.

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Correcting the Public Record about Online Pharmacies and Personal Drug Importation

Correcting the Public Record about Online Pharmacies and Personal Drug Importation

In July of the 2013, the Government Accountability Office (GAO) published a report about Internet Pharmacies with a focus on foreign websites that I believe strongly distorted the public record about buying medication online through personal drug importation. GAO’s report was submitted to Congress in response to Section 1127 of the Food and Drug Administration Safety and Innovation Act, intended to protect the public health. I wrote a report to refute the GAO’s positions in order to correct the public record regarding the intersection of online pharmacies, personal drug importation, drug affordability and the public health. I believe that my report about online pharmacies proves that the GAO’s efforts fell very short in getting to the truth about buying medication online.

Americans buy lower cost and safe medication internationally, often online, and it benefits their health and financial well-being. If it were not for the option of personally importing lower cost medication, often using the Internet, many Americans would just not be able to get medical treatments they need. People who can’t take needed medication often get sick and may even die.  The GAO report did not mention these facts.

The GAO seemed to conflate safe international online pharmacies with rogue online pharmacies in the same manner we’ve come to expect from the pharmaceutical industry, U.S. pharmacy trade associations and the FDA – by calling safe international online pharmacies “rogue.” The problem, for me, is that its lead author is not with the pharmaceutical industry, a U.S. pharmacy trade association, or the FDA. She is someone I’ve come to admire over the years just by following her work with GAO. So I can’t just say “look, it’s big Pharma again!” So for almost a year and a half I’ve written a report to, in part, prove to and remind myself that “we’re right and they’re wrong.” I’ve done that. I look forward to this report becoming a part of the public record.

Rogue online pharmacies, meaning drug-selling websites that are not safe (see my report for details), should be shutdown. Let’s get rid of them! However, if our elected leaders and regulators allow or enact policies to bring about an end to online access by Americans to safe and affordable medication and people get hurt, then they can’t say they didn’t know.

Below, I’ve pasted the cover letter from Tod Cooperman, MD, president of PharmacyChecker.com, and I that accompanied the hardcopy of the report we sent the congressional committees that received the GAO’s report in 2013. Each week we’ll be commenting on and posting the different sections of my report. To read the report now, visit “Online Pharmacies, Personal Drug Importation and Public Health”.

(more…)

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