Kaiser Poll Show Support for Personal Imporatation

Kaiser Poll Show Support for Personal Imporatation

Wednesday, November 2, 2011

Consumer Reports report confuses facts of personal importation

It is always distressing when an old friend, one whose valued advice and knowledge over the years have led to a position of trust and respect, suddenly and inexplicably takes a stance that is at best befuddling, or at worst, just so wrong that is throws into doubt the position of trust that you have accorded them.

That is how I feel today about Consumer Reports. There can be no doubt that over the years, the careful, thorough and unbiased research of ConsumerReports.org has aided untold numbers of Americans to make the most responsible decision purchasing literally hundreds, perhaps thousands, of products.

But, in its recent article, entitledSave money by ordering drugs from Canada? Not so fast’, authored by Len Maniace, Consumer Reports and Maniace present a litany of charges against personal importation. But, as we are always inclined to reach out to an old friend when they go wrong, so we hope the following explanation will lead Consumer Reports back on the correct path, since the article, while it focuses on ‘Canadian’ pharmacies, is a broader attack upon the right of Americans to have access to personal importation of safe, affordable medicines.

(1) The article failed to accurately report the facts surrounding the use of personal importation of prescription medicines from countries outside the U.S., countries whose standards of oversight and efficacy meet or exceed those of the U.S.

a. The fact is that the United States Congress has repeatedly recognized the safety and legitimacy of personal importation having passed legislation to provide access to safe, affordable medicines from licensed registered pharmacies in up to 22 countries only to see the extensive and well-financed lobbyists of Pharma and its trade association, PhRMA use its power to add 'poison pills' of certification of each and every medicine personally imported...a requirement that does not extend to the many medicines imported into this country by Pharma for sale to Americans.

b. The U.S. Food and Drug Administration has adopted a new policy of working on reciprocal agreements with regulatory agencies in other countries in which those countries’ regulatory agencies will validate the safety and efficacy of prescription medicine ingredients. This is a recognition of the long-standing claim by personal importation advocates that such reciprocity could provide the operating framework to facilitate personal importation, and that the FDA’s new stance is a validation of such a process.

(2) While admitting that the cost of prescription medicines in the U.S. are so high (actually the highest in the world, my note) that, monthly and beyond, Americans have problems paying for their prescription medicines, the story line suddenly moves from what one might expect would be an exploration of the issue of prescription medicine prices, with the headline indicating that the question of cost savings (e.g. Save Money question in headline) to ‘reasons’ imported medicines are not safe. Why? Because the story is a boilerplate news release of the National Association of Boards of Pharmacy (NABP) as it resorts to an old saw—that personal importation of medicines from licensed, registered pharmacies is ‘unsafe’ because of the proliferation of bogus pharmacies on the Internet—even though for more than a decade, millions of Americans have purchased safe, affordable medicines from reputable sources outside the U.S.

a. The admission of the problems caused for personal health care by being denied access to safe vital medicines is recognized by a number of disparate groups that now realize that prescription medicine prices in the U.S. are a major driver of healthcare costs that in return are a primary contributor to our fiscal crisis.

b. We are asked to make a giant leap that is a classic non sequitur. The story simply does not follow the headline nor its own lead which both are about costs.

c. Instead, we are subjected to reading the views of a special interest group, a release that is nothing more than an attempt to sew fear by questioning the ability and the rights of millions of Americans to make personal health decisions.

d. At no time does the story indicate that Mr. Maniace has conducted a fact check of the claims of the news release, even though there are many groups and resources to provide facts about the millions of Americans who have saved money while enjoying the health benefits of access to a regimen of safe, affordable medicines to which they otherwise have been denied as admitted in the lead of the story.

(3) The NABP release, which Mr. Maniace adopts virtually intact, goes on to state that many of the pharmacies knowingly sell medicines not approved by the FDA although the record of those sources outside the U.S. that meet the standards cited above provide only FDA-approved brand name medicines or FDA-approved generics. And, since the medicines come from pharmacies in other countries, of course they do not have nor need the approval of the FDA since they have the approval of the countries in which the pharmacies providing the medicines operate. Now the FDA has indicated that it is willing to accept such an arrangement for materials (see (1) (b) above.

a. For years, there have been attempts to disparage the standards of licensed, reputable pharmacies and sources from outside the U.S. by unfairly lumping together those legitimate pharmacies with the admitted bogus pharmacies that many contend ironically exist because of the outrageous and predatory pricing of prescription medicines in the U.S., medicines that are not affordable, which leads to the conclusion that if a medicine is unaffordable, it is equally unavailable and Americans are allowed to purchase medical supplies and/or medicines from outside the U.S. if they are unavailable in the U.S. The following is from the FDA web site stating that a drug is permissable " if the product is for personal use and is a three-month supply or less and not for resale, since larger amounts would lend themselves to commercialization."

(b) Any legitimate source of prescription medicines from the Internet or other sources clearly identifies themselves, insists on a prescription from a personal physician of the patient’s choosing, and who not only meet the standards of the jurisdiction in where they operate but, for many, have established additional standards of quality and safety.

(c) in a disturbing example of blatant disingenuousness, Mr. Maniace quotes Carmen Catizone, NABP’s executive director, who mistakenly claims that many of the Canadian sites are not Canadian at all. Note to Mr. Catizone: I can claim to be a concert violinist, but doing so does not make me one. Those who claim to be ‘Canadian’ but are not, obviously are not what they claim to be. And, while we’re talking about false claims, let’s deal with the onein which Mr. Catizone claims Canadian sources fail to warn consumers of Health Canada’s ‘warning’ about the ‘risks’ of purchasing medicines via the Internet or via personal importation

a. Let’s set the record straight. Here is the verbatim ‘warning’ from the Health Canada site:

“The Status of Internet Pharmacy in Canada

“A number of pharmacies in Canada have legitimate Web sites that offer a limited range of products and services, including information for consumers, and shopping for certain items. The practice of pharmacy in Canada is regulated by the provinces, and any licensed pharmacy that offers Internet services must meet the standards of practice within its own province.

“If you have questions about whether an Internet pharmacy is legitimate, contact the licensing body in your province or territory.

“Minimizing Your Risk

“Do not take any prescription drug that has not been prescribed for you by a health care practitioner who has examined you in person.

“Do tell your doctor and pharmacist about all of the health products you take, including vitamin and natural health products, as well as prescription and over-the-counter drugs. They need this information to assess and advise you about potential side effects and drug interactions.

“If you decide to order drugs on line:

Do not do business with a Web site that:

“refuses to give you a street address, telephone number, and a way of contacting a pharmacist;

offers prescription drugs without a prescription, or offers to issue a “prescription based on answers to an on-line questionnaire;

claims to have a "miracle cure" for any serious condition; or

“sells products that do not have a DIN (see below) issued by Health Canada.

“Do make sure you are dealing with a Canadian-based Web site that is linked to a "bricks and mortar" pharmacy that meets the regulatory requirements in your province/territory.

Finally, if you have a question or complaint about therapeutic drug products purchased on line, call Health Canada's toll-free hotline: 1-800-267-9675”.

(4) The article cites a study by Roger Bate for The Public Library of Science on imported medicines. It notes several failings of the sources from which the medicines were ordered, suggesting that the findings were in agreement with the gist of the Consumer Reports article.

b. Whether it was by oversight or conscious omission, the Consumer Reports article fails to include a key finding of the study. Rather than speak for Mr. Bate, who has followed the course of personal importation for a long period, we choose to reprint the following from his response to the article: (the total response may be found at http://blog.american.com/2011/10/fake-drugs-and-the-internet-consumer-reports-misleads-but-it%E2%80%99s-for-your-own-goodhonest/) (I have highlighted the sections I found particulary pertinent)

“His (Maniace’s) interpretation of that study is accurate, as far as it goes. But it misleads the reader by not explaining the main conclusion of the study. My research team concluded that if one bought from foreign online sellers credentialed by independent group www.pharmacychecker.com, there was no more demonstrated risk than buying from sites approved in the United States by the National Association of Boards of Pharmacy. But to mention this would undermine the message Maniace and Consumer Reports were making in the rest of the article.

“I have no objection to a robust debate about the dangers inherent in buying drugs from foreign websites, but I do object to misleading readers into thinking that all foreign pharmacies and foreign drugs might be lethal. The U.S. Food and Drug Administration is not the only competent regulatory agency in the world and Pfizer and AstraZeneca (the two manufacturers whose products we tested) do not produce worse versions of their medications for Europeans or Canadians as compared with what we might buy in the United States.”

We believe that Americans have the capability to act in a responsible manner to make purchase decisions regarding safe, affordable medicines from outside the U.S. That’s why it is unfortunate when an old friend such as Consumer Reports which rightfully prides itself on the testing and research into products devotes as unfettered fact the boilerplate release such as the Maniace/NAPB story.

We suggest that Consumer Reports consider the health benefits to millions of Americans made possible through personal importation of safe, affordable medicines. It’s a classic example of the Common Sense approach to citizen action to seek relief from the highest prescription medicine prices in the world, and the capability of Americans to act in a responsible manner in making such decisions.

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