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

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…

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

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

· 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

· 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

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

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

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