RxforAmericanHealth

Industry, common sense illustrate why personal importation of prescriptions medicines is safe

2012-01-30T11:37:00.005-06:00

· After more than a decade or working on behalf of providing Americans with access to safe, affordable brand-name medicines from licensed, registered pharmacies outside the U.S., in countries (usually referred to as Tier One countries) whose standards of safety and efficacy meet or exceed those of the United States, I feel compelled to present what I hope will clearly identify why the argument of Pharma and its trade association and many front groups that Americans turning to personal importation of vital medicines to protect their health is flawed.

· There are virtually no prescription medicines sold in this country that are manufactured in the U.S.
· It is a matter of record that prescription medicines personally imported from licensed, registered sources outside the U.S. are subject to the oversight of not one but many regulatory agencies and professional industry groups.
· Significantly, the medicines from licensed registered pharmacies outside the U.S. have a ‘tacit’ endorsement since all are manufactured at U.S. Food and Drug Administration-approved facilities and are subject to FDA Oversight.
· Additionally, the FDA has announced a new operating philosophy in which it will allow reciprocity of importation of ingredients for prescription medicine manufacture. For many years, supporters of personal importation have urged a series of reciprocal agreements with Tier One Countries, similar to that now adopted by the FDA for ingredients. It is only logical that such a concept of reciprocity be extended to personal importation of prescription medicines.
· Brand-name medicines are identical to those offered in the U.S. although they may have additional or different labels applied because of the regulations of the countries in which they are manufactured or to meet requirements of pharmacy regulations within that country. This does not alter the safety, efficacy or authenticity of the medicines but is an indication of the extraordinary levels of oversight.
· The FDA has stepped up its approval of generic medicines, and generics offered for personal importation should be only those already approved by the FDA and offered for sale by US pharmacies.
· Additionally, there are additional levels of oversight offered by the countries in which the manufacturing of medicines must meet the standards of that country.
· Safe medicines have been provided for more than 12 years to millions of Americans from licensed, reputable pharmacies in countries whose standards of oversight and safety meet or exceed those of the U.S., and this proven safety record provides yet another verification of the safety and efficacy of personal importation.
· This includes Internet mail-order pharmacies and pharmacy fulfillment services located in Canada, which are the prime sources of personal importation of prescription medicines in the U.S. Health Canada is recognized as one of the stellar regulatory agencies in the world because of its professionalism and high standards and it has repeatedly noted that these services are in no way violating Canadian law.
· Additionally, legitimate Canadian pharmacies must be licensed and registered by their provincial regulatory bodies, creating yet more impartial regulatory professional oversight to help ensure the safety and efficacy of the medicines and their handling and dispensing.
· To provide additional oversight and assurance of safety and meeting professional standards, legitimate Canadian mail-order pharmacies have established the Canadian International Pharmacy Association (CIPA) to certify that a member pharmacy meets its high standards of safety and quality.
· As an example of the commitment to safety and efficacy, Canadian Internet and mail-order pharmacies, and recognized pharmacy benefit services have also established their own internal oversight services—a Gold Standard so to speak—to be applied to pharmacies outside of Canada to ensure that standards meet or exceed those outlined in this statement and meet their own high standards of the individual entity’s procedures and emphasis upon safety and efficacy.

I submit that these extensive efforts by regulatory agencies, industry members, advocacy groups and policy-makers creates a climate where as one neutral observer has noted that such steps eliminate virtually any chance of a ‘bogus’ operation not being easily identified.

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2012-01-05T09:44:00.000-06:00

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

2012-01-03T15:08:00.003-06:00

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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2011-12-23T09:33:00.000-06:00

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More than 1 in 8 Americans have trouble affording prescription drugs

2011-12-19T10:14:00.000-06:00

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.

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

2011-12-06T10:44:00.000-06:00

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

America's Seniors at TodaysSeniorsNetwork.com

2011-12-06T10:42:00.000-06:00

America's Seniors at TodaysSeniorsNetwork.com

Stop Online Piracy Act endangers health of millions

2011-11-11T12:26:00.004-06:00

The law of unintended consequences is a warning that an intervention in a complex system tends to create unanticipated and often undesirable outcomes

The Stop Online Pharmacy Act (SOPA) claimed by its sponsors to be the answer to protecting the intellectual property of Americans—an admirable goal—is the latest example that will without doubt lead to unintended consequences that will affect the health and well-being of millions of Americans by denying them access to safe, affordable medicines from reputable pharmacies in countries outside the U.S. .

Furthermore, the proposed legislation will not meet its goals, because it will create an unworkable and vague enforcement trigger that does not rely upon a system of law and courts, but instead that allows the Justice Department to cede to private entities the right to initiate action against individuals or websites, with such action carrying with it an assumption of guilt of the party being charged.

I shall leave it to Constitutional experts to illustrate the questionable constitutionality of SOPA. However, I believe it almost certainly will be used as a weapon against free speech and differences of opinion by some who will claim that a promotion of a product or service t violates the intellectual property right of the entity making the charge.

This includes, but is not limited to, the Pharmaceutical industry (Pharma)—an industry whose pricing practices have imposed the highest-cost drugs in the World upon Americans.

This has led to Americans using their common sense and exercising their right—and ability—to make personal health care decisions for more than a decade to purchase safe, affordable medicines. These are the very same ones that would cost at much as 60 percent more,if purchased in the U.S., rather than from reputable sources in other countries, countries whose standards of safety and efficacy meet or exceed those of the United States.

The passage of SOPA would endanger that capability by allowing Pharma to initiate actions against websites or individuals that Pharma could claim was promoting infringement upon its intellectual property rights.

I have mentioned unexpected consequences, Unfortunately, the stage for those consequences has been set by recognized consequences of the pricing of medicines in the U.S.

· 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);

· 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);

It is staggering to consider the negative impact—an unexpected consequence--that will occur as millions of Americans who rely upon personal importation of their safe and affordable medicines find that they must now be without their vital medicines because of legislation supposedly designed to protect American intellectual propert without any consideration of its impact because of the proposal’s vague language.

Fortunately, there is also recognition of the beneficial role of personal importation of vital medicines in protecting the health of Americans:

· 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);

· 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..

So it is now up to the House of Representatives to act, aware that if they sow the wind of SOPA, they will reap the whirlwind of endangering the health of millions of Americans who rely upon personal importation of their prescriptions medicines.

Consumer Reports report confuses facts of personal importation

2011-11-02T13:56:00.009-05:00

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

2011-10-03T16:24:00.005-05:00

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:

· 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);

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

· 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.”

A call for a common sense approach to personal importation of prescription medicines and access to safety, savings, and improved health

2011-08-26T10:47:00.002-05:00

The publisher of a leading informational website on aging issues says that personal importation by Americans of safe, affordable brand-name prescription medicines from Tier One countries remains a primary option to reduce the cost of medicines in the U.S.

Tier One countries are those defined as having standards of safety, efficacy and quality, of prescription medicines and pharmacies and oversight that meets or exceeds those of the U.S.

“The U.S. Food and Drug Administration ( FDA) has recently launched a series of initiatives that call for greater cooperation with regulatory agencies in other countries regarding importation of ingredients into the U.S. for pharmaceutical manufacture,” says Daniel Hines, Publisher of www.TodaysSeniorsNetwork.com and a series of related websites on aging and health issues.

“This indicates the FDA is both willing , and has the power to act to enact such agreements."

He also points to the role of personal importation in reducing the crushing burden of prescription medicine costs in the U.S.

“In a recent interview with Kaiser Health Report, former Senator John Danforth (R-MO) cited the cost of health care as the major problem facing the newly formed ‘Super Committee’ of Representatives and Senators as they must consider recommendations to address the country’s fiscal crisis,” he says.

“The pricing practices of Pharma have been major drivers of the governmental and personal fiscal crises facing the country by spurring the cost of healthcare by raising prescription medicine prices at a rate exceeding inflation and have likely led to bogus internet sources springing up as Americans seek relief from excessive prices ,” Hines says.

“That’s why personal importation of safe, affordable brand-name prescription medicines has passed the U.S. Congress under two administrations over the past 10 years, but the bills which would have established additional safety procedures were made inoperable by the extensive lobbying of Pharma that imposed ‘poison pill’ amendments.

“Deterring the activities of bogus sourcing of prescription medicines and to protect the safety of Americans is commendable and is reflected in the operating credo of those services that have created and adhere to standards of safety, efficacy and quality.

“Americans should not confuse the ability for safe implementation of personal importation that might exist in light of the recent Google settlement regarding internet pharmacy advertising.

”We call on the FDA to extend its new approach towards possible reciprocity and cooperative agreements with agencies, especially those in Tier One Countries, as a means to lower prescription medicine prices in the U.S., thereby contributing to the already proven record of safety, efficacy and quality from medicines being personally imported into the U.S.”

Barrier to effective treatment for seniors - the cost of medicine... Elderly in the US find medication costs prohibitive

2011-08-02T10:44:00.005-05:00

Publisher's Note: While Congress slaps itself on its collective back, the fact remains that no concrete steps have been taken to apply real-life solutions to problems such as the cost of prescription medicines, a major driver of our health care cost crisis which is a prime factor in the fiscal crisis the country faces. The question must be asked: Where are the Senators and Congressmen who have sponsored bill after bill in support of personal importation of prescription medicines? We have noted in previous entries that they have missed an obvious opportunity to advance lower medical costs by not bringing concrete proposals forth. And, ironically, while hailing the effectiveness of Part D, this latest report shows that even with Part D 'benefits', 10 percent or more of America's elderly cannot afford their medicines.

August 2, 2011--As many as one in ten elderly people in the US, registered with Medicare, do not stick to their prescribed medication because it is too expensive, according to Dr. Larissa Nekhlyudov and colleagues from Harvard Medical School. Their work, funded by the National Institute on Aging and the National Cancer Institute, shows that cost-related medication non-adherence - skipping pills to make the medicine last longer, and not filling in a prescription because it is too expensive - is common among this group, whether or not they suffer from cancer.

This suggests that elderly cancer survivors do not face a greater financial burden related to medical costs than those without cancer. The study is published online in Springer's Journal of Cancer Survivorship.

As the population ages, the cost of medicines is rising and there is evidence that this has resulted in financial burden for patients. Cancer costs in particular have grown substantially and patients with cancer are faced with significant out-of-pocket expenses during diagnosis, treatment and follow-up care. Many cancer survivors also take drugs for other chronic illnesses (or co-morbidities), including hypertension, diabetes, hyperlipidemia and osteoporosis.

In order to better understand cancer patients' medication issues, the authors analyzed data from the 2005 Medicare Current Beneficiary Survey and Medicare claims. They looked at cost-related medication non-adherence, spending less on basic needs to afford medicines and other cost-reduction strategies among both cancer survivors and non-cancer sufferers.

Nekhlyudov and team found no differences in the rate of cost-related non-adherence between cancer survivors (10 percent) and those without cancer (11 percent). Six percent of cancer survivors and nine percent of those without cancer also said they spent less on basic needs (such as food and heat) so that they could afford medicines. In addition, more than half of all enrollees used other cost-saving measures, including taking generic medications, requesting free samples and comparing pharmacy prices before buying drugs.

Dr. Nekhlyudov concludes: "As the number of cancer survivors continues to increase and get older, the findings of our study enhance our understanding of the potential barriers to effective treatment of their non-cancer co-morbidities."

Study proves health, costs benefits of access to vital medicines; why I feel validated after panel rejection of such a hypothesis six years ago

2011-07-28T11:24:00.004-05:00

About six years ago at a meeting in DC, I was in a crowded room listening to a panel sponsored by a very large and , among liberal groups , respected organization, talk about healthcare costs.

The Panel included a Ph.D. in healthcare economics. When the QA period came around, I asked her if she could provide any information about what the beneficial impact (overall) of lowering costs might be if Americans had access to safe, affordable medicines including via personal importation.

After she finished laughing at me, (apparently wanting to show their support and that they were not be mistaken to be , as I obviously was, a part of the great body of unwashed and ignorant people from outside The Beltway, the rest of the room joined in ) she brushed me off saying she just couldn’t see how lower medicine costs could be beneficial because of the enormity of the problem of what causes medical costs to rise, an issue which she noted I obviously didn’t understand.

I suggested that perhaps if people had access to lower-cost medicines there might be enhancement of the health and well-being of the patients taking the meds meaning that they could avoid future procedures, methods that would be more costly. The moderator then stepped in and asked for the next question. Today I feel validated by the following article Part D saved Medicare money, study finds

I believe my point was validated by the story since it seems to me that the same case can be made for those who, were it not for personal importation, would be denied the health benefits of a regimen made possible through access to safe, affordable medicines . And, by extension, if those who are denied the health benefits of access to a regimen of safe, affordable brand-name prescription medicines were able to afford their medicines, they would avoid later, more expensive and possibly life-threatening medical complications.

But, this will require a new appreciation of the importance of dealing with specifics of issues, avoiding the broad, sweeping—and largely theoretical and esoteric discussions that while providing intellectual satisfaction to those who claim superior knowledge because of their academic credentials do not consider issues from the perspective of everyday Americans. The story follows (highlighted areas are mine):

Part D saved Medicare money, study finds

Spending more money on drug therapies actually can be thrifty, at least for Medicare patients. That's the conclusion of a new study by Harvard Medical School and Brigham and Women's Hospital. As the Boston Business Journal reports, the researchers found that Medicare Part D, which subsidized drug purchases, led to lower costs for non-drug care.

Published in the Journal of the American Medical Association, the study compared medical spending on non-drug treatment both before and after Medicare Part D was implemented in 2006. Researchers used data from 2004 to 2007 on Medicare recipients who had limited drug coverage before Part D and on those who already had drug coverage when the new program came into force.

The researchers found that Part D cut other healthcare spending by about 10% per patient, or $1,200, for the group who had little drug coverage before the program. Costly inpatient care appeared to be reduced the most, while more cost-effective outpatient care wasn't affected as much. That's how drug treatment is supposed to work, of course, but this study offers dollar signs as hard evidence.

The Part D data ought to inspire Medicare to look at better integration of care, the researchers said. "These reductions in non-drug spending suggest Part D has not cost Medicare as much as initially expected," study author J. Michael McWilliams, a Harvard Medical School professor, said in a statement (as quoted by the BBJ). "This study exemplifies how spending on one type of service can affect spending on other types of care, which suggests that greater coordination and integration could lead to...higher value healthcare for elderly Americans."

Nation’s Health Care Bill To Nearly Double By 2020

2011-07-28T10:21:00.004-05:00

By Phil Galewitz

KHN Staff Writer

The federal health law, which will expand coverage to 30 million currently uninsured Americans, will have little effect on the nation's rising health spending in the next decade, a government report said today.

The report by the Medicare Office of the Actuary estimated that health spending will grow by an average of 5.8 percent a year through 2020, compared to 5.7 percent without the health overhaul. With that growth, the nation is expected to spend $4.6 trillion on health care in 2020, nearly double the $2.6 trillion spent last year.

Health law critics said the report confirmed their concerns. "Most of us understood the health reform law was about expanding coverage not cutting costs," said Joseph Antos, a health policy expert at the conservative-leaning American Enterprise Institute.

But White House Deputy Chief of Staff Nancy-Ann DeParle said the report showed Americans were getting a good deal. "The bottom line from the report is clear: more Americans will get coverage and save money and health expenditure growth will remain virtually the same," she said on the White House blog.

DeParle, who helped lead the White House efforts on the overhaul, said several delivery system reforms being tested under the health law will work to lower spending. "We know these new provisions will save money for the health care system, even if today’s report doesn’t credit these strategies with reducing costs," she said. She pointed to new programs that administration officials have said they hope to implement changing the way Medicare and Medicaid pay doctors and hospitals.

National health spending in 2010 grew at its slowest rate ever recorded – 3.9 percent – as a result of more Americans forgoing treatment because they had lost their jobs and their health coverage, said the report, which is being published online today by the journalHealth Affairs. In 2009, health spending grew by 4 percent.

The report estimates that spending on health will accelerate this year because the economy is expected to improve and people would have more disposable income to spend on medical care.

In 2014, when the major coverage expansions of the health law begin to take effect, national health spending is expected to grow 8.3 percent, according to the new analysis. But spending growth should return to its 6 percent historical average from 2015 to 2020 as some employers drop coverage and the so called "Cadillac tax" on high-cost insurance plans takes effect in 2018. "The effect is likely to be a slowdown in the growth of health services, health insurance premiums and health spending overall," the study said.

Meredith Rosenthal, a health economist at Harvard School of Public Health, said it is difficult to predict what impact the health law will have on slowing national health spending. "Many of the components of the law that are intended to control costs are still in draft form," she said citing experiments such as accountable care organizations and bundled payments that change how Medicare pays providers.

The number of Americans with employer-sponsored insurance will grow from 163 million last year to 170 million in 2014, the report estimated. But by 2020 that number is expected to drop to 168 million as a result of two factors: Baby Boomers joining Medicare and employers dropping health coverage for workers. Most of those workers would turn to new state insurance exchanges – or marketplaces –or Medicaid, the federal-state health program for low-income and disabled people.

The issue over how many employers would stop offering coverage has been a political flash point since the health law was approved in March 2010. Democrats maintain most employers would continue to provide coverage, but Republicans and other critics predict many companies would drop it because their workers will be able to go to new health exchanges. Starting in 2014, the health law requires all employers with 50 or more workers to provide coverage or pay a fine.

The Congressional Budget Office — the neutral scorekeeper — estimates that, by the end of the decade, 3 million fewer people will get health insurance from their employer. That’s slightly more than the Office of Actuary prediction.

The study authors stressed their projections could vary depending on many factors, including the overall state of the economy and how quickly people sign up for new coverage.

"These projections are definitely uncertain and that increases as we move along in the projection period," said Sean Keehan, a study author and an economist in the Office of the Actuary.

The Medicare actuaries acknowledged that they were off on one of their estimates last year. At that time, they predicted that national spending in 2009 would grow by 5.8 percent, instead of the 4 percent growth that the report said actually occurred. Keehan said one of the factors helping push that prediction off the mark was that fewer people than expected joined COBRA plans after losing their jobs and that resulted in fewer people with health coverage and less spending.

The office also predicted last year about 375,000 people would sign up for new Pre-existing Condition Insurance Plans by 2013. But since the plans began a year ago under the health law, only about 20,000 people have signed up.

CMS Chief Actuary Rick Foster attributed the lack of public awareness of the new insurance pools for the less-than-anticipated participation. He said his office took into account the low participation rates in making estimates for enrollment in Medicaid and insurance exchanges starting in 2014.

The report estimated about 13.9 million people would enroll in new state-based insurance exchanges in 2014 and the number of uninsured would drop by nearly 20 million in that year. Given how many millions of eligible people don’t sign up today for Medicaid, that prediction is highly speculative, said Steven Findlay, an analyst at Consumers Union.

PhRMA stands behind role in Healthcare negotiations

2011-07-13T12:24:00.003-05:00

The following Publisher’s note is the opinion of Daniel Hines and RxforfAmericanHealth.blogspot.com, and does not reflect the viewpoint of Kaiser: The interview is reprinted here as a public service to offer insights into the workings of a powerful lobby within The Beltway. Gone are the days that legislation was shaped by citizen involvement, public hearings, and testimony from concerned citizens with specialized knowledge, not special interests: Yesterday we blogged about how PhRMA’s role in the behind-closed-door Healthcare Reform ‘negotiations’ and its supposed savings for Seniors in The Doughnut Hole really were a Magic Lantern Show. The following interview and PhRMA’s comments about not being able to identify the true extent of the savings provide, we believe, validity to our observations.

The complete, unedited interview/story follows:

PhRMA Chief Says Support For Health Law 'Was Right Decision'—The KHN Interview

By Bara Vaida

JUL 13, 2011

One year after John Castellani took control of PhRMA, the former manufacturing executive has steered the drugmakers' lobbying group to be ready for battle with the White House.

Gone are the days where the Pharmaceutical Research and Manufacturers of America, is making deals with a Democratic White House and spending $101 million on advertising to promote the new health law. That was the successful strategy of PhRMA’s previous leader, former Rep. Billy Tauzin, R-La. to ward off new regulations for the industry in the law. Now PhRMA has signaled that it will fight any attempt by congressional Democrats or the White House in the current deficit reduction talks to save money by cutting drug spending in government programs.

In a hastily scheduled press conference this week, Castellani made it clear that PhRMA opposes a Democratic proposal that would require drugmakers to pay rebates to the Medicare program for beneficiaries who qualify for both Medicare and Medicaid, known as the "dual eligibles." He said it would "do serious harm to the industry, serious harm to (pharmaceutical) jobs and we oppose it. … We opposed it in the context of the discussions around the [health law] and we oppose it now." And if the proposal succeeds, Castellani said there "would be the risk" that drug companies would begin to move their operations to countries outside the U.S.

Still, Castellani says the industry doesn’t regret supporting the health law because he says it "was the right decision under the political context at the time," although his group would like to see some changes in the law.

Castellani recently spoke with Kaiser Health News' Bara Vaida. Here is an edited excerpt:

Q. PhRMA made a $80 billion to $100 billion deal with the Obama administration during the health reform debate to stave off more regulations, angering many of your Republican allies in Congress. Are you sorry the industry made that deal?

A. No. No. It was the right decision under the political context at the time. You had a Democratic president and a Democratic Congress and sweeping legislation that affected our industry. The decisions that were made were appropriate given the political circumstances.

Q. How much was the final deal? $80 billion or $100 billion? What number is right?

A. I can't comment given the nature of how [the Medicare rebate] affects individual companies.

Q. You have said you would like to see the Independent Payment Advisory Board (IPAB) in the health law repealed. What are you doing specifically to lobby on that?

A. IPAB is fundamentally flawed. It has to be repealed in its existing form or mitigated. What we have been doing is talking to other groups that are affected by it and talking to members of Congress. There is a substantial bipartisan effort to repeal [IPAB] that is almost unrelated to what we are doing about it.

Q. The president targeted the drug industry in his recent deficit reduction plan, how do you feel about that?

A. The president proposed to shorten the period of data exclusivity for biologics. It was disappointing and a bit surprising. He talked in the State of the Union speech about owning the future and investing in technology, and (his efforts on biologics) is discouraging what he wanted to encourage.

Q. What about the deficit reduction plan proposed by Rep. Paul Ryan, R-Wis. Would you support or oppose that? Do you see any dangers to the drug industry?

A. We don't know enough about it. We do think we need to have a debate about how do you fundamentally change Medicare so that it can be affordable (for the future). All ideas ought to be on the table.

Q. What are you doing to manage the drug industry's reputation with the public? People feel drug companies charge too much for their products.

A. Obviously we need to be trusted by public policymakers and by patients and by clinicians, and that is something that we are committed to doing. The problem is the delivery system by which people get medicines. [The system] is designed to disproportionately show the cost of medicine, so even though we are only about 10 percent of total health care costs, we are 40 percent of out-of-pocket expenses. That makes people think that we are the most expensive part of the health care, when in fact we may have the most value and be much less expensive than acute care. The other problem is that we haven't done a good enough a job of explaining the scientific process in how difficult and potentially rewarding it is and we need to help people understand where we fit in the economy and the kinds of jobs we produce and the kinds of value-added we provide.

Q. What about PhRMA's political reputation? Some Republicans remain angry over your support for health reform?

A. People try to portray us as Democrat or Republican. We are not. We are pro PhRMA. Lawmakers that recognize the value of PhRMA to their states and the economy and the costs of medicine are the people we support. The grumbling will always be there. There will always be someone who will find a reason why we should be doing something differently than we are going to do.

Q. You've acknowledged the industry spent about $25 million in the 2010 election cycle to get candidates elected. How much will you spend in the 2012 cycle?

A. We will support the candidates that support the industry, and I don't know who that is yet. It's too early. Really. I am not playing hide the peanut. I will tell you when I know (how much) it is.

Q. You say 75 percent of all prescriptions filled are generics rather than brand-name, what does that mean for PhRMA and the industry's business model?

A. Generics are an important part of the medicine life cycle. We produced all of them. They are our children. But if you are going to continue to innovate, you have to continue to support returns for the inordinate investment it takes to find new medicines. It is $1 billion to $1.3 billion over 10 to 12 years to develop a new medicine, so you have to have the mix of patent protections if you are going to have the rewards for that innovation. If you don't want to pay for the innovation, then you have to say to American patients, we have invented everything that we can invent. But we don't believe that. There are still discoveries out there. The problem with what the president proposed and when people say we ought to go to all generics, is generic companies don't spend money on research and development. We do.

Q. What about comparative effectiveness. PhRMA on its blog says it is a good thing, but the industry fights it.

A. Here is one of the issues that is difficult to deal with. The discovery process is an iterative one. Let's take some of the work done on HIV/AIDS. When (researchers) started out, you were talking about extending life for six months, then a year, then 18 months and then over years it turned HIV into a chronic disease. Clinicians learned, and the results got better over time. Comparative effectiveness can be good if it looks at the spectrum of the options available over a long enough period of time to know what the real value is.

Kaiser Health News reporter Mary Agnes Carey contributed to this article.

Why Congress and the President should embrace personal importation of prescription medicines to reduce costs of health care, stimulate economy

2011-07-12T09:41:00.000-05:00

What must be described as the most, ‘Oh, Really?” news coming from The Beltway is the headline from the Los Angeles Times to let us know that “ Drug Makers Seek To Block Deficit-Talk Demands For Discounts.”

The Pharmaceutical Industry has never really stopped spending millions of dollars to protect its ability to impose the highest drug prices in the world on U.S. citizens, prices created through back-door, secret deals with Pharma by people who are supposed to represent the public interest, namely bureaucrats, Congressmen and Senators, and sadly, in the most recent example, the President of the United States himself.

I say sadly, because then-Senator Obama was in favor of personal importation of safe, affordable brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries whose oversights and standards of safety meet or exceed those of the United States.

He was even a co-sponsor of the Dorgan-Snowe bill, the Pharmaceutical Market Access and Drug Safety Act supporting the concept of personal importation

However, it really didn’t matter since in what had become a ritual of each session of the U.S. Senate, the proposed legislation failed to receive the votes needed for passage.

So, it was with a great deal of anticipation that we looked forward to the newly elected President Obama, confident that he would take advantage of the huge Democrat majorities in the House and Senate to break the hold of Pharma upon the nation. .

But, in a classic case of Inside The Beltway hubris, the new legislation brought forth by Senators Snowe and Dorgan was troublesome although on the surface, it appeared to be the same legislation as previous attempts.

However, many supporters of personal importation, including me, believed that the proposed legislation had a fatal flaw—namely too great an emphasis upon medicines from Canada to the exclusion of those from Australia, New Zealand, et al., since at the time, sources from the Canadian International Pharmacy Association (CIPA) were estimating that as much as 80 percent of the brand-name medicines being sold by Canadian mail order pharmacies were from Tier One countries other than Canada.

Supporters who questioned the intent of the bill were told by staff to like it or lump it (a direct quote). So, the enthusiasm for the legislation, not the concept, dwindled among many who would otherwise have supported the bill enthusiastically as they had done for years.

At the same time, the President immediately found that the pharmaceutical industry was just the sort of strange bedfellow that he could lie down with. In return for support of his Healthcare ‘Reform’, the President claimed that he had negotiated with PhRMA, the trade association of the pharmaceutical manufacturers, to provide relief for Seniors trapped in the Doughnut Hole by reducing the prices of their meds for the beleaguered Seniors by 50 percent. Utilizing the funny math that has become a Hallmark of his Administration, the President based his Administration’s estimates of the savings upon existing drug prices.

Of course, Pharma immediately, began raising its prices at a rate that far outstripped the Cost of Living, and, since the 50 percent deal didn’t kick in for a year, recouped much of the hoped-for and claimed savings.

The deal with Pharma was just one small part of the closed-door sessions of special interests that led to the botched opportunity to address the real problem of health care in the United States—as Jimmy McMillan noted about New York rents: “The rent is too damned high.” The same is true of the role of prescription medicines: “The cost is too damned high.”

In a touch of irony, one of the pivotal figures of the ‘Gang of Six’ during the Health Care debate was Senator Snowe, the co-author of the previous Dorgan-Snowe bills supporting Personal Importation. (In what has become an annual rite, Senator Snowe is the Co-Sponsor with Senator Debbie Stabenow (D-MI) of this Senate session’s resurrected bill seeking to allow personal importation of prescription medicines.(Publisher’s Note: Like previous versions of the proposed legislation, the language was crafted by staff. Rep. Ron Paul (R-TX) has a House bill to allow personal importation in the hopper, and his version is much simpler, reflecting his Libertarian leanings. His bill would allow Americans to make their own decisions about where to purchase prescription medicines and to trust their common sense to exercise good judgment in discerning sources of safe, effective medicines free of what some believe is a burdensome—and possibly costly—oversight requirement in Senators Snowe’s and Stabenow’s version, which has a number of co-sponsors.)_

The web site, WhoRunsGov, noted that Senator Snowe and her staff were working to “exert her outsize influence on the healthcare bill.” Unfortunately, even with her record of support for lowering prescription drug prices, the Senator was unable to utilize that ‘outsize influence’ to get true price reduction in prescription medicine via price negotiation or personal importation. Instead, Pharma racked upon another victory.

But, contrary to the old saying about how many times opportunity knocks (once if didn’t know), President Obama and Speak John Boehner (R-OH), now have a unique opportunity to address one an issue that could provide a true stimulus to the tottering economy by putting billions of dollars in consumer pockets, reduce the deficit by billions, and do so all while providing the health benefits that access to a regimen of access to vital medicines can provide—embrace the right of Americans to act in a responsible manner exercising their own good judgment to step up their purchases of safe, affordable brand-name medicines from Tier One Countries outside the United States.

Estimates are that consumers could save as much as $80 billion over the next decade, and that the Federal Government could reap savings of $19 billion in the same period.

It is hard to explain why our elected officials have been so unable to grasp what is a win-win situation—improved health for U.S. citizens, more money for consumers to spend on necessities and, perhaps, even some non-essential items for their own enjoyment. In a recent speech on the Senate Floor, Senator Dick Durbin (D-IL) noted that the continuing costs of healthcare were a major contributor to the fiscal crisis the nation faces. It seems it might be a grudging admission that the real problem caused by the President’s Affordable Care Act (Obamacare) was that the emphasis should have been on cost-containment and not coverage.

But, it’s another case of the American people being ahead of those inside The Beltway, where an atmosphere of immunity from real-life problems prevails. The fact is that for more than a decade, literally millions of people have turned to personal importation as a safe source of vital brand-name medicines. It is time for the Obama Administration and Congress to embrace the benefits personal importation can provide for even more Americans, knowing that by so doing, they will be acting in the best interests of the health and well-being of Americans, while derailing Pharma’s role as a major driver of health care costs.

Americans' access to personal importation of brand-name prescription medicines from Tier One Countries threatened by proposed legislation

2011-06-16T12:26:00.003-05:00

As the debate continues over what is commonly referred to as ‘Obamacare’, one would think that there would be universal support for an effort that has a more than decade long record of lowering health care costs, providing vital, safe—and affordable medicines—that have contributed to the health and well-being of millions of Americans, and done so at no cost to local, state or Federal governmental agencies.

We’re talking about the right of Americans to purchase brand-name prescription medicines from licensed, registered pharmacies in Tier One countries outside the U.S. whose standards and oversight of safety and efficacy meet or exceed those in the U.S.

But, instead of support of this recognition of the right—and ability—of Americans to make responsible decisions in the selection of these legitimate pharmacies for the purchase of brand name prescription medicines at savings of as much as 60 percent compared to what they would have to pay for the very same medicines if purchased in the U.S., the U.S. Senate is advancing legislation that could empower the Pharmaceutical Industry (Pharma) to use what many believe are Constitutionally questionable legal maneuvers to deny more than one million Americans the ability to order safe, affordable brand-name medicines from outside the U.S. via the Internet.

The Protect Intellectual Property Act (Protect IP) has been introduced by Senator Frank Leahy (D-VT), the chair of the Senate Judiciary Committee, to supposedly protect American Intellectual property such as Copyrights from being used in counterfeit items.

Protect IP was authored by Senator Leahy after there was a vigorous outcry of opposition to an earlier anti-counterfeiting bill advanced by the Senator because fears that its vagueness could be used to tread upon legitimate debate on public issues. The first proposal never came to a vote in the Senate because Senator Ron Wyden (D-OR)exercise a personal objection that prevented a vote.

Senator Leahy’s solution to the objection has been to bring forth an even more onerous proposal that contains specific language of the type supported by the Pharmaceutical Research and Manufacturers of America (PhRMA) in its ongoing campaign against Americans exercising their right to the health and cost benefits of purchase of brand-name medicines from reputable pharmacies with the highest standards of safety and efficacy.

The Protect IP Act would create a situation in which the Obama Administration's Justice Department would abdicate its responsibility to 'enforce' intellectual property rights to the private sector.

This means that Pharma could not only initiate legal action against anyone it believes has 'infringed' upon its intellectual property s, it could extend that action to websites whose advertising support includes pharmacies involved in personal importation. Many believe that the proposal would allow Pharma to initiate action against a website that supports the concept of personal importation, thereby limiting free speech and open debate.

If that is not disturbing enough, Pharma could seek an immediate injunction against anyone it

'believes' has committed infringement in some form or another, all the while doing so

free of any action against it should its suit be found to not have merit.

In the past decade, Congress has repeatedly passed legislation over the supporting the concept of personal importation of these medicines as the only viable option available to lowering the cost of prescription medicines in this country.

Such initiatives have faltered in the face of extensive lobbying by Pharma as it uses its vast resources to deter final passage with such gimmicks as ‘poison pills’ amendments that would place unnecessary restrictions upon personal importation such as ‘certification’ in addition to the rules and laws of the country from which the prescription was dispensed by adding a layer of ‘oversight’ which was really nothing more than the U.S. Congress responding to the intensive lobbying of Pharma lobbyists.

That’s why RxforAmericanHealth.com has launched an on-line petition supporting access for more than one million Americans to personal importation of safe, affordable brand-name prescription medicines. We must let Congress and other policy-makers know that this concerted effort by Pharma to protect its ability to continue to charge Americans the highest prices for prescription medicines in the world is totally unacceptable.

Instead, it is time for Congress and the Obama Administration to remove the ‘Safe Haven’ that Pharma enjoys to continue its predatory pricing practices and make the health and well-being of hard-pressed Americans for whom personal importation can provide not only improved health that access to a regimen of vital medicines provides, as well as offering the best strategy to relief from the high prescription medicine prices that are a major driver of the cost of healthcare in the United States.

Dramatic Price Increases in Brand Name Drugs spur Shareholders to action…

2011-04-28T09:01:00.002-05:00

Investors from the Interfaith Center on Corporate Responsibility (ICCR) say new policies are needed to reign in drug costs

NEW YORK, April 27, 2011 /PRNewswire-USNewswire/ -- 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.

The group is citing several benchmarking reports including one from the General Accountability Office this past February that found branded drugs consistently outpacing generics relative to inflation (6.3% vs. 3.8%). ICCR members are asking management for pricing that hews closer to the consumer price index, a strategy they believe is a more accurate reflection of value and a more sustainable policy over the long term.

The Centers for Medicare and Medicaid Services projects that U.S. prescription drug spending will grow 93% during 2008-2018, exceeding all major categories of health expenditures. AARP reports that the branded prescriptions most widely used by Medicare patients increased 9.7%, far exceeding the cost for other consumer goods in the last 12 months: prices for generics during the same time period fell. ANovember 2010 report from Deloitte Consulting concluded that the issue will intensify, and that current pricing practices are not sustainable.

"The evidence from all the studies is clear, " said Ed Gerardo, director, Community Commitment and Social Investments of Bon Secours Health System, Inc. " Measures must be taken to control costs and bring transparency into the drug pricing equation."

Resolutions are on the ballots at the nation's top pharmaceutical companies including Johnson and Johnson, Abbott, Bristol-Myers Squibb and Pfizer, requesting that management utilize a combination of approaches to keep drug prices at reasonable levels.

ICCR members have been in dialogue with pharmaceutical companies for decades on issues of access and affordability.

Cathy Rowan, consultant to Trinity Health, said, " Many of us represent health care systems with missions to enhance the health of the communities they serve. We would like to see the pharmaceutical companies in which we invest have access to medicines at the heart of their business strategies."

"This isn't about charity or foregoing a profit," said Laura Berry, Executive Director of ICCR. "Our members expect that the companies they invest in espouse policies, pricing and otherwise, that promote both justice and sustainability while enhancing shareholder value. The absence of clear and reasonable pricing policies is neither just for consumers nor sustainable as a business practice."

Barbara Aires, coordinator, Corporate Responsibility, the Sisters of Charity of St Elizabeth, said, " It's hard to justify these increases in this economy. More and more, people have to choose between buying groceries and picking up their prescriptions and when people can't afford to take their medicines they get sick, straining an already fragile health care system. Our company needs a rational pricing policy that keeps branded products affordable and accessible to consumers yet will remain competitive to generics when patents expire."

About the Interfaith Center on Corporate Responsibility ( www.iccr.org ):

Currently celebrating its 40th year, ICCR is the pioneer coalition of active shareholders who view the management of their investments as a catalyst for change. Its 300 member organizations with over $100 billion in AUM have an enduring record of corporate engagement that has demonstrated influence on policies promoting justice and sustainability in the world.

SOURCE Interfaith Center on Corporate Responsibility

Cost of heart drugs makes patients skip pills, putting themselves at risk

2011-04-14T10:25:00.002-05:00

For more than 5 million Americans with heart failure, a critical step to better health is taking the medications they're prescribed. But many patients fail to do so, putting themselves at greater risk of hospitalization and even death. To date, studies have not fully answered why patients fall short when it comes to taking heart medicine.

In a study appearing in the April issue of Mayo Clinic Proceedings, Mayo Clinic researchers found the drugs' cost is one of the biggest deterrents.

"We found patients weren't filling their prescriptions because of the expense," says Shannon Dunlay, M.D., Mayo Clinic cardiologist and lead author.

The study recruited patients from Olmsted County, Minn., and tracked their pharmacy records. Previous studies looked only at electronic prescription claims data, possibly missing drugs purchased with cash or not covered by insurance, Dr. Dunlay says.

The 209 patients in the study, ages 60 to 86, were asked how often they missed doses or didn't take drugs at all, and why.

Researchers found that younger patients were slightly more likely to skip certain heart medications than older patients.

Men were less likely than women to stick to certain drug regimens. Among patients who did a poor job following prescriptions, financial concern was the main reason: 46 percent reported that they had stopped taking statins or not filled a prescription because of cost, and 23 percent acknowledged skipping doses to save money.

Although 77 percent of patients in the study were eligible for Medicare, medication costs were still an important issue for some of them.

Dr. Dunlay emphasizes that heart failure patients worried about medication costs should tell their physicians. There often are lower-cost alternatives, she says.

Why RxforAmericanHealth believes personal importation of medicines from Tier One Countries can lower our debt at the local, State and Federal levels

2011-02-18T14:46:00.001-06:00

· The United States faces what many believe to be the most severe fiscal crisis of its history—the burdensome Federal debt.

· Forty cents of every dollar spent by the government is today being applied to payment of interest for the debt.

· As of January 31, 2011 the amount of the U.S. debt had grown to $14.6 trillion.

· While there is debate among policy makers with differing political beliefs about contributors to this crisis, a consensus is rapidly emerging that a major contributor is the cost of healthcare.

· While the rate of the growth of healthcare costs has diminished somewhat, this is due to individuals not utilizing services due to the economic recession.

· At the same time, Prescription drug spending accelerated in 2009 to $249.9 billion, increasing 5.3 percent after 3.1 percent growth in 2008, driven by faster growth in both prices and utilization, according to the report.

· This reflects the fact that the pharmaceutical industry (Pharma) is a major driver of the ongoing—and growing—fiscal crisis as it relates to the costs of healthcare.

· ‘Negotiations’ between the Obama Administration and the pharmaceutical industry have not only not reduced the costs of prescription medicines, but they have actually created a guaranteed market for Pharma that will generate additional sales of drugs to be paid for by the Federal Goverment as the Doughnut Hole Medicare Part D is gradually eliminated, and as Pharma has continued to raise prices to offset its promise to ‘reduce’ prices for America’s elderly utilizing Medicare Part D.

· The result has been to increase prices for prescription medicines for all Americans, all the while failing to offer true relief for the elderly, but adding to the burden of the Federal debt.

· There must be relief from the prices Americans pay for prescription medicines—the highest in the world.

· Allowing personal importation of brand-name prescription medicines is the most effect strategy to provide the competitive forces to reduce the negative impact upon personal and governmental budgets, and at the same time, enhance the health and well-being of Americans by providing a healthcare regimen that includes access to safe, affordable brand-name medicines.

o Access to safe, affordable prescription name-brand medicines from licensed, regulated pharmacies outside the U.S. will reduce costs of medications, while improving the health of U.S. citizens

o Every American is entitled to enjoy the health benefits made possible by prescription medicines.

o We believe that Americans are capable of making informed decisions about his or her personal health and can do so in a responsible manner.

· This is validated by the growing number of policy makers—including President Obama—who in January 2011 reiterated his oft-stated campaign position regarding personal importation as a means of lower prescription drug prices, and reflected his sponsorship of legislation allowing personal importation when he served in the U.S. Senate.

· The President is not alone. A growing number of members of the U.S. Congress has introduced or announced support of personal importation as a primary driver as an option to offset increased healthcare costs directly, and, therefore the Federal debt.

· · The pharmaceutical industry has conducted an ongoing campaign comprised of false charges, inaccuracies, and fear tactics to damage the reputation of companies, services and individuals supporting a role for brand-name prescription medicines from outside the U.S.

· This is a reflection of Pharma’s goal to protect the status quo, as well as to make moves to prevent the free market from offering Americans the opportunity to purchase lower-cost safe brand-name medicines, and the industry’s belief that Americans are not capable of making such responsible decisions.

· · We shall present the truth about the safety, efficacy and cost-savings of brand-name prescription medicines from licensed, registered pharmacies in Tier One countries where standards of safety and efficacy meet or exceed those of the U.S.·

· We shall support policies allowing U.S. citizens to exercise their right to freedom of choice in brand-name prescription medicine purchases from licensed, registered pharmacies outside the U.S.

More on The Combating Online Infringement and Counterfeits Act and personal importation of prescription medicines

2011-02-14T12:31:00.003-06:00

· Personal Importation of safe, affordable prescription medicines from countries outside the U.S was spurred more than a decade ago as a reaction to the fact that the U.S. has the highest prescription drug prices in the world.

· Personal importation of prescription medicines is the only option available to provide lower-cost brand name medicines for Americans.

· These medicines—from licensed, registered pharmacies in Tier One countries with standards of oversight that meet or exceed those of the U.S.—have provided health benefits and financial relief to hundreds of thousands of Americans.

· The U.S. Congress has through repeated votes in the House and Senate expressed its support of the concept of making personally imported medicines available to U.S. citizens from pharmacies in Tier One countries.

· While a rash of bogus pharmacies and counterfeit medicines has arisen on the Internet, legitimate on-line pharmacies have taken extraordinary steps to distinguish themselves from bogus pharmacies.

· The pharmaceutical industry and its trade group (PhRMA) have targeted the right of personal importation of prescription medicines, which, ironically, they themselves have manufactured.

· The latest attempt to curtail access to personal importation is to define any online pharmacy from outside the U.S. as ‘bogus’ , even if an online pharmacy has met the standards of safety and efficacy of its practice required by the appropriate regulatory agency of its government.

Opponents of personal importation have taken steps that indicate they hope to use the anti-counterfeiting intent of The Combating Online Infringement and Counterfeits Act as a rationale to claim that even licensed, registered pharmacies would be guilty of infringement of Copyright and Intellectual property rights

This would make the pharmacy liable to enforcement provisions of The Combating Online Infringement and Counterfeits Act which include, but are not limited to, the shutting down of domains and websites not only of the pharmacy, but could be extended to the sites of advocacy groups and individuals that support personal importation.

· Because of that, specific legislative language should be included in The Combating Online Infringement and Counterfeits Act to ensure that the legislation meets its intended purpose, and cannot be co-opted by special interest groups that would utilize the bill to meet their own narrow interests.

Without the inclusion of language to more carefully define the intent of The Combating Online Infringement and Counterfeits Act the stage would be set for the pharmaceutical industry to take actions to restrict the right of Americans to enjoy the health benefits provided by safe, vital medicines that they otherwise could not afford.

Publisher of informational Website for Seniors says Congress must clarify language of anti-counterfeiting bill to deter Pharma moves

2011-02-14T11:23:00.006-06:00

The publisher of a leading informational website for America’s Seniors says that Congress must clarify the language of The Combating Online Infringement and Counterfeits Act (COICA) which is ostensibly designed to deal with the issue of the theft of U.S. intellectual property rights and counterfeit products sold in the U.S., to deter attempts by the pharmaceutical industry (Pharma) to co-opt the legislation for its own limited purposes

Daniel Hines, publisher of www.TodaysSeniorsNetwork.com and http://RxforAmericanHealth.blogspot.com says that Pharma is attempting to utilize the ambiguous definition of ‘counterfeit’ as it applies to brand-name prescription medicines from licensed, registered pharmacies in Tier One countries as a new tactic to prevent Americans from utilizing personal importation of vital prescription medicines.

The Committee is holding a hearing Thursday, February 16, featuring representatives of Visa, Verizon, GoDaddy.com, Authors Guild and Rosetta Stone.

"Pharma has long attempted to deny access to safe, affordable medicines from Tier One Countries through its extensive lobbying among elected officials and with appointed /policy-makers, “ Hines says. “Now, it is attempting to co-opt the intent of The Combating Online Infringement and Counterfeits Act.

“This is unacceptable to those who believe Americans should be able to exercise their right to make personal health care decisions, including the purchase of safe, affordable medicines from licensed, registered pharmacies from Tier One Countries, whose standards of oversight for safety and efficacy meet or exceed those of the U.S."

Hines noted that "Pharma has spared no expense to create a series of 'front groups' to create the specter of 'bogus pharmacies' flooding the country with unsafe prescriptions, and to go so far as to attempt to falsely include legitimate pharmacies from Tier One Countries.

"But it has shown no interest in directing its vast resources to establishing the mechanism and framework which could address the best means of distinguishing 'rogue pharmacies' from legitimate, licensed pharmacies in Tier One countries.

“The reason for Pharma's opposition to personal importation-ironically, importation of the very medicines that they produce under FDA oversight-is that the imported medicines are priced at 40 to 80 percent less that the identical medicine in the U.S., Hines says. “These tremendous savings provide access to safe, affordable medicines that enhance the health and well-being of large numbers of Americans.

"We urge the Committee members and other Senators and members of Congress to pay special attention to ensuring that the language in The Combating Online Infringement and Counterfeits Act encompasses the real goals of deterring copyright and intellectual property theft, by clarifying the intent of the use of the term ‘counterfeit’, and that there be specific and clearly defined restrictions upon efforts by special interest groups to co-opt the intent of the bill."

"The health interests of large numbers of Americans receive utmost consideration and Pharma interests must be restricted from utilizing the legislation to attain its long-standing goal of limiting the access of Americans to vital medicines,” he concluded.

US Drug Watchdog says Recalled Pain Drugs Darvocet and Darvon could kill

2011-01-18T12:46:00.000-06:00

Publisher’s Note: The following release from US Drug Watchdog adds to a growing body of evidence that calls into question the intent of the pharmaceutical industry as it attempts to persuade policy-makers that it should have a major policy-making role in oversight of determination of the safety of safe, affordable prescription medicines from licensed, registered pharmacies in Tier One countries. To elevate an industry that is—or should be—subject to the strictest governmental oversight to a prominent role to help determine the processes of the agency—in this instance, the FDA—that is charged with providing oversight of that industry’s manufacturing processes is completely irrational, particularly when that industry (Pharma) has a proven record of manufacturing processes that expose Americans to potential harm to their health as well as proven fraud. The release follows:

The US Drug Watchdog is calling the recalled pain pills Darvocet, Darvon, or the generic propoxyphene some of the most lethal drugs ever sold in the United States, and is urging all US citizens to stop taking Darvocet, Darvon, or the generic version propoxyphene pain pills immediately.

“We are astonished with how many people we have talked with, who took Darvocet, or Darvon, had a heart attack, developed severe heart rhythm issues, and now are either medicated to control their heart beat, or they have a pacemaker. This should be on the national news every day," the group says.

The US FDA ordered a recall of these drugs on November 10th 2010, yet there is a worry that most consumers have not yet heard of the recall.

US Drug Watchdog says, "22 million US citizens have used the recalled pain pills Darvocet, Darvon. These recalled pain pills can cause severe heart problems including, heart attacks, sudden deaths, or severe heart damage.

“We need to hear from every Darvocet, Darvon, or propoxyphene user, who has developed severe heart issues, or heart problems."

For more information please call the US Drug Watchdog at 866-714-6466, or contact the group via its web site at http://USDrugWatchdog.com

"We don't think-we know the recalled Darvocet, Darvon, or the generic version propoxyphene are still being used by millions of US citizens, these specific types of pain pills have been associated with heart rhythm issues, heart attacks, sudden death, and many users now have pacemakers, because of the damage done by these widely used medications," the group continues

"These pain pills have killed completely innocent US citizens, and our number one goal is to identify every individual in the United States, who has used the recalled Darvocet, or Darvon, and then developed heart rhythm issues, heart attacks, or other severe complications, including having to now have a heart pacemaker.

“We now fear it’s in the 10,000's.

"If you, or a loved one has suffered from abnormal heart rhythms, heart attacks, or other heart problems while taking Darvon, Darvocet, or the generic propoxyphene, please call us immediately at 866-714-6466." Darvocet, or Darvon victims can also contact the US Drug Watchdog via its web site at http://USDrugWatchdog.com

What are some typical symptoms experienced by many Darvocet, or Darvon pain pill users?

The US Drug Watchdog indicates the serious side effects that they are aware of with respect to Darvocet, or Darvon users are as follows:

Heart Arrhythmia

Heart Attack

Suicide

Overdose

Sudden Death

The US Drug Watchdog , the premier private pharmaceutical watchdog in the United States, concludes with the following alert:

"The Internet, and cable TV are loaded with advertisements, about compensation for Darvocet, or Darvon users, ads talking about Darvocet, or Darvon class actions, and or lawsuits, related to heart attacks, or heart rhythm problems.

“Unfortunately, the vast majority of the attorneys, or law firms advertising for help with heart conditions, heart attacks, or even sudden death after using the recalled Darvocet, or Darvon are middlemen marketing law firms-not the actual trial law firms, that will prosecute these cases.

"We want to make certain the Darvocet, or Darvon victims get to the actual trial law firms, or attorneys, that have the best record in achieving significant results for their clients-not a middleman marketing law firm." http://USDrugWatchdog.com
Federal Case No. 2:10-cv-04455

New Consumer-based organization in support of personal importation of prescription medicines launches national campaign

2011-01-12T17:01:00.007-06:00

New Consumer-based organization in support of personal importation of prescription medicines launches national campaign

The RxRights Coalition, comprised of advocacy organizations around the country that are concerned about the high cost of pharmaceuticals in the U.S., has launched an outreach and communications program to ensure that Americans are able to exercise their right to access to safe, affordable medicines from licensed and registered pharmacies in Tier One Countries who standards of oversight and efficacy meet or exceed those of the U.S.

Lee Graczyk, acting director of Mature Voices Minnesota, the lead organizer for the Coalition, explains that that vital medications are often too expensive for American consumers because of the predatory pricing practices of the Pharmaceutical industry.

“Personal importation not enhances the health and physical well-being of huge numbers of Americans by allowing them to benefit from the access to vital medicines, and provides financial relief for Americans with prices that are as much as 60 percent less for the very same medicines,” Graczyk explains.

Graczyk points out that Congress has repeatedly passed legislation favoring personal importation, only to see it turned back by extensive lobbying by unmanageable amendments promoted by Pharma.

Now, even though it has made agreements with the current Administration, Pharma continues to raise prices at a pace exceeding the inflation rate, Graczyk explains.

Graczyk also points to the record of safety and efficacy of personal importation of medicines.

“We believe that Americans have the capability to act responsibly in exercising their right to purchase their medicines,” Gracyzk says. “There are many ways of verifying legitimate pharmacies, and one of the most important is their record of providing safe medicines.”

Graczyk himself can point a more than decade-long-history of working on behalf of safe, affordable medicines.

In his role as public policy director of the Minnesota Senior Federation, starting in 1999 he organized monthly bus trips to Canada to ensure that seniors could obtain affordable prescription drugs. The Federation collaborated with then-Senator Mark Dayton to fund this project. For six years, Senator Dayton donated his entire senatorial salary to the cause.

The bus trips helped bring national public attention to all Americans’ need for access to safe and affordable prescriptions, and the Federation soon realized that more than the bus trips were needed to provide access to the medicines. What was required was providing them with the ability to order prescription drugs online, bringing greater convenience and savings to even more Americans.

Graczyk was instrumental in establishing a prescription drug importation program for the Federation. He scrutinized more than 20 Canadian companies, and approved those with the highest standards for the program. All met the standards of Health Canada, the Canadian equivalent of the U.S. FDA

The program is now maintained by Mature Voices Minnesota and currently has 2,200 members. Participants save anywhere from 20 to 80 percent on their prescription drugs by using the service.

Additionally, Internet importation has become a “virtual lifeline” for millions of Americans—a lifeline the RxRights consumer coalition is working to protect to allow continued access to safe and affordable prescription prescription medicines.

The Coalition is a partnership of organizations throughout the country that support reimportation in order to expand this influence. The Coalition’s goal is to inform and educate both the public and elected officials on the issues surrounding prescription drug sales in this country.

Reasons to Join this Effort:

The prices that Americans pay for prescription medicines are the highest in the world.

A prescription drug one cannot afford is neither safe nor effective.

Every American is entitled to enjoy the health benefits made possible by prescription medicines.

Access to safe, affordable prescription medicines from licensed, regulated pharmacies outside the U.S. will reduce the costs of medications and improve the health of U.S. citizens.

Lack of competition in the U.S. allows pharmaceutical companies to fix prices and overcharge Americans.

The Coalition Pledges to:

Present the truth about the safety, efficacy, and cost-savings of prescription medicines from outside the U.S.

Support policies allowing U.S. citizens to exercise their right of freedom of choice in determining where they purchase their prescription medicines.

What You Can Do:

Join the coalition

Sign the petition

Tell your friends about the website

Contact your Senators and Representatives and let them know that you support prescription drug importation

Follow RxRights on Twitter, Facebook and YouTube

The Coalition holds regular teleconferences to discuss safe and affordable drug importation. Contact Lee Graczyk to join the Coalition or for more information.

List of Coalition Members

CMS: Healthcare spending increased to $2.5 trillion in 2009, Drug Prices Up

2011-01-10T10:24:00.003-06:00

Publisher's Note: The pharmaceutical industry has once again led the way in price increases, indicating, we believe, that the only relief that hard-pressed Americans will receive from the predatory pricing practices of pharma will be through allowing U.S. citizens to make their own health decisions and have access to safe, affordable medicines--the very same medicines produced by pharma and sold in the U.S. at prices as much as 60 percent higher that those prices outside the U.S.--from licensed, registered pharmacies in Tier One Countries.

The recession slowed healthcare spending in 2009, according to a Centers for Medicare & Medicaid Services (CMS) report on national health expenditures. However, sectors including prescription medications and freestanding home healthcare services logged increases.

Although U.S. healthcare spending increased 4.0 percent in 2009, this represented a drop from the 4.7 percent increase in 2008. Total health expenditures reached $2.5 trillion, or $8,086 per person in 2009—17.6 percent of the nation’s gross domestic product (GDP), according to the report.

Hospital spending increased 5.1 percent to $759.1 billion in 2009, compared to 5Publish Post.2 percent growth in 2008.

Growth in 2008 and 2009 was much slower than the trend between 1999 and 2007, when spending increased an average of 7.2 percent per year.

The slower growth in 2009 was influenced by decelerating private health insurance spending and slower price growth. Partially offsetting these factors was an increase in Medicaid spending, as Medicaid enrollment increased considerably in 2009, CMS stated.

Spending on physician and clinical services increased 4.0 percent in 2009 to $505.9 billion, a deceleration from 5.2 percent growth in 2008. Slower growth in the use and intensity of services in 2009 was partially offset by increasing prices. Spending for other professional services, such as physical therapy, chiropractic medicine, and mental health, also decelerated in 2009, increasing 5.3 percent to $66.8 billion. Spending in this area increased by 6.6 percent in 2008.

Spending for residential and personal care services accelerated in 2009, increasing 8.3 percent to $122.6 billion compared to 4.6 percent growth in 2008.

This category includes expenditures for medical services delivered in non-traditional settings, such as schools or community centers, ambulance providers, and residential mental health and substance abuse facilities.

In addition, spending for freestanding home healthcare services increased 10 percent in 2009, to $68.3 billion, following growth of 7.5 percent in 2008.

Spending for freestanding nursing care facilities and continuing care retirement communities increased 3.1 percent in 2009 to $137.0 billion, a deceleration from growth of 5.0 percent in 2008.

Prescription drug spending accelerated in 2009 to $249.9 billion, increasing 5.3 percent after 3.1 percent growth in 2008, driven by faster growth in both prices and utilization, according to the report.

Spending for durable medical equipment, which includes items such as eyeglasses and hearing aids, decreased 0.8 percent to $34.9 billion after increasing 2.3 percent in 2008.

Spending for other non-durable medical products, such as over-the-counter medicines, decelerated in 2009, increasing 2.2 percent to $43.3 billion compared to 3.1 percent growth in 2008.

Medicare spending grew 7.9 percent in 2009 to $502.3 billion, the same rate of growth as in 2008. Spending for fee-for-service (FFS) Medicare accelerated in 2009, increasing 5.5 percent, compared to 4.4 percent growth in 2008.

Medicare Advantage (MA) spending increased 15.8 percent in 2009 following 21.4 percent growth in 2008 and was primarily attributable to a continuation of significant increases in MA enrollment. Total Part D spending (which includes spending for benefits, government administration, and the net cost of health insurance) increased 9.3 percent to $54.5 billion in 2009.

Total Medicaid spending grew 9.0 percent in 2009 to $373.9 billion, an acceleration from 4.9 percent growth in 2008, and was driven by a 7.4 percent increase in Medicaid enrollment.

Federal Medicaid expenditures increased 22 percent, while state Medicaid expenditures declined 9.8 percent. This difference in growth is due to a significant increase in the Federal Medical Assistance Percentages (FMAP) used to determine federal Medicaid payments to states—a provision of the American Recovery and Reinvestment Act of 2009 (ARRA).

Private health insurance premiums grew 1.3 percent in 2009, a deceleration from 3.5 percent growth in 2008. Benefit payment growth also slowed, from 4.4 percent in 2008 to 2.8 percent in 2009.

“These trends were heavily influenced by the recession as private health insurance enrollment declined.

"In 2009, spending for benefits increased faster than premiums, and as a result, the net cost of private health insurance (or the difference between premiums and benefits) fell to an 11.1 percent share of total private health insurance spending from 12.4 percent in 2008—a continuation of its recent decline,” CMS stated.

Out-of-pocket spending grew 0.4 percent in 2009, a deceleration from 3.1 percent growth in 2008, as these expenditures declined for dental services, nursing care facilities and continuing care retirement communities, and physician and clinical services, according to the report.