New Congressional proposal is ‘third leg’ of Pharma-driven legislation designed to ensure ‘The United States of Pharma’ as a safe haven for highest

Publisher's Note: While Pharma and its allies have vast funding, there is still an opportunity for the average American to make his or her voice heard, and to pull the props out from the Pharma Stool. RxRights.org has mounted a vigorous citizen-based campaign by which citizens who know the benefits of personal importation can easily utilize state-of-the-art communications with their Senators or Representatives to make the case for Americans to not being denied continued access to safe, affordable medicines.

On September 27, 2010 and October 26, 2010, we warned that the Obama Administration and the Pharmaceutical Industry were engaged in a series of actions designed to end Americans’ access to safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One Countries outside the U.S.—countries whose standards of safety and efficacy meet or exceed those of the U.S.—as a part of a strategy to ensure that citizens of ‘The United States of Pharma’ continued to pay the highest prices in the world for their medicines.

At that time, we paid special heed to a radical departure by Pharma from the traditional method of encouraging that FDA and Customs, acting in collusion, to deny access to vital medicines by seizures of prescription drugs from pharmacies outside the U.S. that they claimed were ‘illegal’ even though they were the very same medicines sold in the U.S. at prices of as much as 60 percent more.

Having had such strategy rejected by the U.S. Congress, which denied the use of governmental funding for such seizures, Pharma’s new technique was to co-opt legitimate legislation ostensibly designed for purposes not related to the goals of Pharma, but to address other concerns—specifically, the protection of intellectual property rights of U.S. individuals and companies by deterring the excessive counterfeiting made possible by their promulgation of sites specializing in infringement activities with bogus goods.

The first two ‘legs’ of the ‘legislative stool’ were the Protect IP Act (formerly Hatch-Leahy) and the Stop Online Piracy Act (SOPA), both of which we vigorously opposed with letters to Senate and House Judiciary Committee members and selected health care staff to point out how the law of unintended consequences—namely, the perverse effect of endangering the health and well-being of millions of Americans who could be denied access to vital medicines—would override any beneficial effects of the bills, solely because of the Pharma-influence.

The co-opt process was launched by a number of Pharma front groups that built upon the fact that there are admittedly ‘bogus’ pharmacies in many countries that produce unsafe, knock-off medicines and are able to utilize the Internet to attempt to deceive Americans, ironically because the predatory pricing practices of Pharma have made them so expensive as to be beyond the reach of untold numbers of Americans.

Now, in what can only be described as the ‘third leg’ of the ‘legislative stool’ policy of the Pharmaceutical Industry (Pharma) to attempt to co-opt the legislative process to its own ends, Senators Feinstein (D-CA), Schumer (D-NY), Sessions (R-AL) and Cornyn (R-TX) have introduced a proposal that they claim will help ‘protect’ Americans against being duped by bogus pharmacies doing business on the Internet.

The misnamed bill, ‘The Online Pharmacy Safety Act’, is actually nothing more than an attempt by which the U.S. government incorporates into Health and Human Services (HHS) programs a number of groups that have received funding over the years from Pharma in the industry’s efforts to deny millions of Americans access to safe, affordable prescription brand-name medicines from licensed, registered pharmacies outside the U.S.

The bill is misleading in both its title and the Pharma boilerplate language. It would be better named, ‘The U.S. Internet Pharmacy Act,’ and its attempts to ‘criminalize’ any and all pharmacies not verified by the new directory that the legislation would establish.

The new ‘directory’ is actually nothing more than the VIPPS verification service already promulgated by Pharma and the National Association of Boards of Pharmacy. Of course, no pharmacies from outside the U.S. would be allowed to be ‘registered’, which gives clue to the real reason for the legislation—to attempt to present U.S. Internet and mail-order pharmacies as the only source of safe prescription medicines via the Internet even though for more than a decade millions of Americans have purchased safe, affordable medicines from licensed, reputable pharmacies in other countries. Also, there is no requirement that all—or even any—U.S.-based Internet Pharmacy seek to be included in the registry.

Ironically, the Canadian International Pharmacy Association already has a ‘verification’ list of members, all approved by their provincial licensing authority, but none of those sites would be eligible for inclusion in the HHS site. Also, reputable sources for pharmacy services have established their own standards, including rigorous inspection of the licensed pharmacies that service millions of Americans.

But the goal of the legislation is to cast doubts about the safety and efficacy of those operations by ‘criminalizing’ them.

An example of the ‘boilerplate’ attempt to create an impression that by not being in the directory, those pharmacies are ‘criminal’ is to highlight the real problem of ‘bogus’ pharmacies, and to indicate that any source of personal medications from outside of the U.S. is, in and of itself ‘criminal’ because they are outside the U.S. Consider these excerpts from the proposed legislation (in the interest of space, I have used only segments pertaining to ‘criminality’ and the threat to health and life of the bill’s language. I have highlighted portions to illustrate how contrived and disingenuous is the attempt to ensnare all Internet pharmacies from outside the U.S. ). The bill’s rationalization follows, accompanied by my comments in bold face.

Bill Language: (2) illegal online drug sellers offer products that do not meet the safety standards established by United States laws, and recent reports from the National Association of Boards of Pharmacy show that 92 to 95 percent of Internet websites offering to sell prescription medications online are illegitimate and operate in clear violation of United States laws enacted to protect patients; …

(4) the World Health Organization estimates that 50 percent of the prescription medicines sold online by Internet websites that hide their physical address are counterfeit… research by The Partnership at Drugfree.org found that 1 in 6 consumers in the United States, a total of about 36,000,000 Americans, has bought or currently buys prescription medication online without a valid prescription…

The facts:

While the FDA has said personally importing prescription medicine is ‘illegal’, for years, the it has ‘allowed’ Americans to cross into Canada to purchase prescription medicines for their personal use in the U.S. To deny Americans who do not have proximity to the Canadian border the right to make similar purchases via the Internet from those same pharmacies or sources denies them the right of equal protection in the exercise of their right to make personal decisions regarding their health that are available to one group of U.S. citizens but not to them, merely because they lack proximity to the Canadian border. Also, while the FDA says that personal importation is not allowed, its own policies note:

"when 1) the intended use [of the drug] is unapproved and for a serious condition for which effective treatment may not be available domestically either through commercial or clinical means; 2) there is no known commercialization or promotion to persons residing in the U.S. by those involved in the distribution of the product at issue; 3) the product is considered not to represent an unreasonable risk; and 4) the individual seeking to import the product affirms in writing that it is for the patient's own use (generally not more than 3 month supply) and provides the name and address of the doctor licensed in the U.S. responsible for his or her treatment with the product or provides evidence that the product is for the continuation of a treatment begun in a foreign country/area."

The Facts: Simply put, the medicine that is unaffordable is unavailable

.

More Bill Language: (6) the prevalence of illegal online drug sellers, and their sale of counterfeit or otherwise illegitimate

medicines, is a growing public health threat…

(7) people have been seriously injured or killed by products sold by illegal online drug sellers…

(8) the accessibility of controlled substances and other drugs without a valid prescription by

illegal online drug sellers contributes to a growing prescription drug abuse problem in the United States that is endangering teenagers and public health…

(9) the anonymous and unregulated nature of the Internet contributes to the counterfeit drug trade and enables counterfeit medicines to reach United States consumers through illegitimate online drug sellers posing as legitimate pharmacies;

(10) counterfeit drugs that are sold through illegal online drug sellers are manufactured by criminals who deliberately and fraudulently misrepresent the product in order to trick consumers into thinking they are purchasing a legitimate and safe medicine…

The Facts: As to Americans being seriously injured, in response to an inquiry about Canadian pharmacies and other legitimate pharmacies, “The FDA's Director of Pharmacy Affairs, Tom McGinnis, says, "I can't think of one thing off the top of my head where somebody died or somebody got put in the hospital because of these.” And, As then-Governor Tim Pawlenty said in his famous response to claims by Pharma of the lack of safety and efficacy of those medicines : “Show me the dead Canadians”.

The facts about the benefits of personal importation are self-evident. We see them in the improved health and well-being of friends and neighbors. We see them in the savings afforded to individuals and groups for whom personal importation is the only (and best) alternative to either paying the highest drug prices in the world with is dire personal fiscal consequences, or depriving themselves of vital medicines with its drastic health consequences of being denied the health benefits of access to a regimen of safe, affordable and necessary medicines. The legislative initiative of Pharma threatens all of these.

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More than 1 in 8 Americans have trouble affording prescription drugs

WASHINGTON, December 19, 2011– The proportion of Americans reporting problems affording prescription drugs remained level between 2007 and 2010, with more than one in eight going without a prescribed drug in 2010, according to a national study released today by the Center for Studying Health System Change (HSC). Despite the flat numbers, the news isn’t necessarily good.

The most vulnerable people - the uninsured, those with low incomes, people in fair or poor health and those with multiple chronic conditions - continued to face the most unmet prescription needs, according to findings from HSC’s 2010 Health Tracking Household Survey, a nationally representative survey with information on 17,000 people.

Funded by Robert Wood Johnson Foundation, the survey for the first time included a cell phone sample to account for the growing number of households without a landline phone. Response rates were 45 percent for the landline sample and 29 percent for the cell phone sample.

[See also: Prescription co-pays rise for healthcare workers]

Although the percentage of consumers who had trouble paying for drugs leveled off, that might be an indication that they did not see a doctor to get a prescription.

“The stability may reflect the fact that fewer people went to the doctor and received a prescription, making it possible that the results are not capturing the full extent of affordability problems,” said Ellyn R. Boukus, HSC health research analyst and coauthor of the study with HSC Senior Researcher Emily R. Carrier, MD.

“While prescription affordability problems did not worsen overall, rates remained high (more than one in eight Americans went without a prescribed drug),” continued Boukus. “This was especially true for the most vulnerable groups, whose reliance on prescription drugs is highest. About half of people in fair or poor health and almost 70 percent of those suffering from multiple chronic conditions reported foregoing a prescription in 2010 because of cost concerns.”

Given the large increase in the uninsured population - from 42.8 million in 2007 to 51.7 million in 2010 - and financial pressures caused by the severe economic recession and sluggish recovery, the study points out that it is somewhat surprising that drug affordability problems did not increase.

One factor that likely made some prescriptions more affordable for patients is the loss of patent protection for several major branded drugs and additional shifts toward generic use.

“More patent expirations are on deck for some widely used drugs such as Plavix (for heart disease) and Actos (for diabetes), which will help to improve affordability,” said Boukus. “However, in the short term, it is possible that prices for brands that are soon going off patent will rise as drugmakers take advantage of their remaining exclusivity.”

Senators question Pfizer and health care companies about agreements to obstruct generic Lipitor

Senators question Pfizer and health care companies about agreements to obstruct generic Lipitor

America's Seniors at TodaysSeniorsNetwork.com

America's Seniors at TodaysSeniorsNetwork.com

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, entitled’ Save 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.

Common Sense approach can lower drug prices, improve fiscal and personal health

St. Louis, MO, October 3, 2011--In response to many stories identifying cost-related challenges created by high prescription medicine prices, the publisher of a leading informational web site dealing with issues of an aging America, has issued a statement that a ‘Common Sense’ approach to personal importation of prescription medicines offers the most immediate and viable option to the problems created by prescription drug prices in the U.S., the highest in the world:

Daniel Hines, publisher of www.TodaysSeniorsNetwork.com notes that:

“For more than a decade, we and other advocates and groups have worked both individually and collectively to provide Americans relief from the highest prescription medicine prices in the world by supporting their right and recognizing their capability to make responsible decisions in their purchases of safe, affordable medicines from proven reputable sources outside the U.S

“Concurrently, we were among the first to identify the potential of the detrimental fiscal impact for both citizens and government of high prescription medicine prices, when, nearly four years ago, we first called for the U.S. government to ‘just do it’ in regards to lowering prescription drug costs

“Now, with the continuing fiscal crisis facing local, state and Federal governments, and with millions of Americans unemployed, there is a finally a growing consensus among a growing number of groups and policy-makers that healthcare costs are indeed a primary driver of our budgetary crisis, and, significantly, that prescription medicine prices are a major contributor to healthcare costs.

“The problem calls for a ‘Common Sense’ resolution such as presented again in a statement we made in August of this year , namely that ‘Common Sense’ recognizes the beneficial contribution of personal importation to addressing recent reports that define the extent of the crisis caused by healthcare and prescription drugs costs:

· As the skyrocketing costs of brand name drugs leave millions of Americans skipping doses or abandoning their prescriptions, investors representing 14 faith and health care organizations are petitioning the nation's top pharmaceutical companies to re-examine pricing for commonly used drugs like Lipitor, Plavix and Celebrex in an effort to make them more affordable;

· Cost of heart drugs makes patients skip pills, putting themselves at risk (Mayo Clinic);

· U.S. prescription drug spending will grow 93% during 2008-2018, exceeding all major categories of health expenditures (Centers for Medicare and Medicaid Services);

· Americans failing to fill prescriptions or not taking their medicines as prescribed because of costs of medicines (Consumer Reports);

· Bi-partisan identification of the problem of healthcare costs in resolving our fiscal crisis (Senator Richard Durbin (D-IL), former Senator John Danforth (R-MO);

· Recognition of the ‘safety valve’ function of personal importation in preventing prescription medicine prices from going even higher “Basically, what’s going on with Canada is a little bit of leakage, It’s a release valve so that American consumers don’t get more upset with the prices’’ ( Arthur A. Daemmrich, assistant professor of business administration at Harvard Business School);

· Formation of a Congressional Caucus by Representatives Joanne Emerson (R-MO) and Peter Welch (D-VT) to work to lower prescription drug prices (Representative Emerson is a long-time supporter of personal importation of prescription medicines);

· Reports of Seniors falling Into Doughnut Hole buying fewer drugs (Kaiser Family Foundation);

· As many as one in ten elderly people in the US, registered with Medicare, not have access to their prescribed medication because it is too expensive (Dr. Larissa Nekhlyudov and colleagues from Harvard Medical School);

· Adoption of a new policy by the FDA facilitating importation of ingredients for pharmaceutical manufacture in the U.S. to address drug shortages in this country via reciprocal agreements with regulatory agencies in other countries, validating a process of reciprocity long advocated by supporters of personal importation;

· Numerous private and government support systems exist to help ease the cost for America's poor, but there are still millions of patients who are uninsured, and many who can't find cheap medicines in the U.S. look abroad… To avoid high prices at home, U.S. patients have trekked to Canada for decades to buy their medicines… pharma companies and myriad industry-funded groups have scared Americans into believing that drugs from overseas pharmacies are inherently dangerous (American Enterprise Institiute);

· Introduction of legislation by Senators Al Franken (D-MN) and Amy Klobuchar (D-MN) supporting personal importation to relieve the growing problem of shortages of medicines in the U.S..

“These actions/situations from diverse groups reflect the extent of the problems and challenges caused by the pricing practices of Pharma that have made the cost of medicines in the U.S. the highest in the world, Hines says.

“ The most immediate and viable solution to these challenges is a ‘Common Sense’ approach protecting the right of Americans to purchase their safe and affordable medicines from reputable sources outside the U.S.

“The FDA’s actions for reciprocal agreements with other countries regarding ingredients for pharmaceutical manufacture can be a model for addressing questions of safety and efficacy.

“And, last but not least, we believe that for more than a decade, the safety and efficacy of personally imported medicines has been demonstrated by millions of Americans utilizing their ‘Common Sense’ validating that they are capable of acting in a responsible manner in making prescription drug purchases.”