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.

Time for critics of importation to look closer to home

Our most recent posting, actually a reposting, of an earlier criticism of Dr. Marv Shepherd, who, in his role as Director of the Center for Pharmacoeconomic Studies and Chairman of the Pharmacy Administration Division at the University of Texas-Austin College of Pharmacy, warned about the dangers of prescription medicines sold via internet mail-order pharmacies, suggesting that anyone making such an order, risked getting unsafe and/or counterfeit medicines, prompted a response from one reader who suggested that we lacked the courage of our convictions because while the Doctor 'signed' his papers, we published anonymously.

The writer failed to notice that sections of our blog site clearly identified us as the publisher of the site, so we expanded our identification. Interestingly, the critic had signed his/her response, 'Anonymous'.

But to move on. Let's see how concerned Dr. Shepherd and others who make misleading charges in an attempt to discourage individual importation of safe, affordable medications from licensed registered pharmacies are about the safety standards of the pharmaceutical industry itself.

This news release from the Missouri Attorney General indicates how two leading manufacturers risked the safety of Americans by their failure to report negative effects of two medicines they produced.

It is especially interesting to note that the attorneys general of 36 states were involved in the 'settlement' with Merck and Schering-Plough, but look where the drugs come from--Singapore, where the companies had a joint venture, named somewhat uncreatively MSP-Singapore.

So here is our standing invitation to Dr. Shepherd to show that he is truly concerned about prescription drug safety and holding pharma accountable for honest, open communications.

Using the University's PR budget, we urge him to do a study on bad medicines foisted upon the American public. Identify the companies, the medicines, and the potential health impact of the deception of pharma. Then, issue a news release about the need to make sure that pharma doesn't endanger the health and well-being of Americans.

The release follows. It is evident that the health threat to U.S. citizens from the misinformation of pharma is more of a threat than personal importation of safe, affordable prescriptions from licensed, registered pharmacies in Tier One countries.

Attorney General Koster announces Missouri to receive $100,000 in
settlement with Merck and Schering-Plough
--drug companies slow to disclose negative drug-study results--

Jefferson City, Mo. -- Attorney General Chris Koster today
announced a multi-state settlement with Merck & Co. Inc, Shering-Plough
Corporation, and a joint venture of the two companies, MSP Singapore
Company, LLC.

“When pharmaceutical companies slow reports of negative
drug-study results they are as good as lying to the public,” Koster
said. “It is unconscionable that a drug company would withhold
information that physicians and their patients need to make good
health-care decisions,” Koster said. “The agreement with Merck and
Schering-Plough sends a strong message that this Attorney General’s
office will be vigilant on public health issues and that we will not
allow businesses to put profits before patients.”

The settlement resolves an investigation into the companies'
lengthy delay in releasing negative results from the clinical trial
called ENHANCE (Ezetimibe and Simvastatin in Hypercholsterolemia
Enhances Atherosclerosis Regression). In this study, the
cholesterol-lowering drug Vytorin (a combination of the drug Zetia and
simvastatin) was no more effective reducing formation of plaque in
carotid arteries than the cheap, generically available
cholesterol-lowering drug simvastatin. Although ENHANCE ended May 2006,
a partial reporting of negative results did not occur until January 2008
and complete results were not published until the following April.
Prior to release of study results, Vytorin had been heavily promoted in
direct-to-consumer advertisements.

The settlement terms that now apply to Vytorin and Zetia are
requirements to:

● Obtain pre-approval from FDA for all direct-to-consumer
television advertisements;

● Comply with FDA suggestions to modify drug advertising;

● Register clinical trials and post their results;

● Prohibit ghost writing of articles;

● Reduce conflicts of interest for Data Safety Monitoring
Boards that ensure the safety of
participants in clinical trials; and,

● Comply with detailed rules prohibiting the deceptive use
of clinical trials.

In addition to these terms, the companies agreed to pay the
investigation costs of the 36 states participating in the settlement.
Missouri will receive $100,000 for its work on the investigation.

Dorgan-Snowe needs changes

Sometime ago, we published a blog suggesting that problems that we perceived with the proposed prescription medicine importation bill, based on our understanding of input from key staff and communications with other supporters of the concept of the prescription medicine importation led us to fear that key elements of the concept that have long been supported by groups and advocates might somehow not be included in the new legislation.

It was that concern that prompted us to call for increased public participation in the development of the language. Irrespective of what the outcome might have been for our appeal, we believe that such involvement is not only a right given to U.S. citizens, but an obligation for those whom we elect to serve and govern--not rule.

Our specific concerns were that we and others have long believed that it is the right of U.S. citizens to make purchases from Tier One countries, where the regulations, oversight and supervision of pharmacies meet or exceed those of the United States.

We were challenged on this by a visitor to the article who wanted our source to validate the statement. She speculated that it was likely a political reference and tht the FDA had not reached such a conclusion. Of course, she was right on the latter aspect, since the FDA would never face the wrath of pharma by stating the obvious. In the former instance, though, she was just wrong. The fact is that each of the Tier One countries have outstanding regulatory oversight, and it is well-recogized by healthcare professionals and authorities around the world that not only do those countries have standards that meet those of the U.S. and the FDA, but that we as a country are unforunately far behind the standards of those countries.

Which leads to our former concerns about the proposed importation legislation that was was introduced on March 4. We feared that the ability of U.S. citizens to purchase physician-prescribed medicines from Tier One countries was to be limited, and would allow the purchase of medicines from those countries only if they were first purchased by a U.S. importer (a pharmacy, group of pharmacies, or a wholesaler) for resale to Americans.

This seemed to be an unnecessary restriction that would only add to the costs, while doing nothing for safety or efficacy of the medicines.

Unfortunately, the latest 'wrap' explanation of the bill seems to reinforce this view.

After much discussion, and readings of the bill regarding the limitation on individual purchases we came to the mistaken conclusion that the Secretary of HHS would be able to 'designate' particular countries as having standards of oversight and regulation that met or exceeded those of the U.S. and that individuals would be allowed to make purchases from those countries.

The latest explanation of the proposed language has disabused us of our mistake. To the contrary of what we believed, it reinforces our earlier fears and limits direct purchase to mail-order or Internet pharmacies located only in Canada.

This would take effect 90 days after the passage and signing of any importation bill. At the same time, it would be a year before the 'commercial' setup that would allow American citizens to purchase those same medicines from designated countries, and then only from a wholesaler or a U.S. pharmacy.

As one who has supported the concept of importation of medicines from legal, authorized, licensed pharmacies for nearly six years, it is difficult to express my dismay at this short-sighted approach to increasing the access of Americans to safe, affordable prescription medicines--especially at a time when growing numbers of elderly are either reducing or doing without vital medicines because of the problems associated with the Doughnut Hole. And that is only the tip of the iceberg.

Millions of Americans irrespective of their age simply cannot afford their medicines, so they too do without. Ironically, this occurs at a time when there is a solution--expand the ability of Americans to have increased access to safe, affordable medicines, exercising their own good judgment by utilizing the many sources that identify legitimate, safe pharmacies in Tier One countries.

As a writer from the American Enterprise Institute (no friend of importation) noted recently, "Only an idiot would purchase 'medicine' from a bogus pharmacy" because there are many sources than can identify legitimate pharmacies.

The legislation has been referred to the Senate Health, Education, Labor and Pensions Committee and to the House Energy and Commerce committee. Hopefully, there will be hearings at which public testimony will be solicited--and listened to--as part of the democratic process.

I have been told that I am covering old ground. Perhaps that is true. But the facts are evident: importation from licensed, registered pharmacies is a fact and even with (or perhaps because of Part D), it offers a reasoned solution to allowing Americans to have access to vital medicines; to the best of my knowledge, there have been no deaths from any medicines from these pharmacies; no controlled substances have been shipped to this country from these pharmacies.

And,whereas there was no track record when the push for importation first began, and it would have been necessary to establish safeguards to protect and reassure the American public, there is no guarantee that even with passage of the legislation in its current form that it will end or even curtail bogus pharmacies, sales of controlled substances or sales of counterfeit drugs.

The concept of importation, free choice and equitable pricing, with the goal of improved health that can be attained through a regimen of access to safe, affordable medicines remains valid. The challenge now: to establish the framework that will make it happen.

A pivotal year

Although we have not posted for sometime, the upcoming and much anticipated inauguration of President-elect Obama and a new Congress means that healthcare certainly will become a major national issue and it is time to restore a sense of urgency to activities.

In the 'lapse', much has already been accomplished:
--Advocates of importation of prescription medicines have regrouped and are planning strategies in support of importation, likely under the auspices of a revised Dorgan-Snowe impetus led by Senator Olympia Snowe (R-ME) and Senator Byron Dorgan (D-ND) . The National Council of Consumer Organizations, a part of the National Council on Aging, is leading the effort with respected senior advocacy leaders Peter Wyckoff, the former executive director of the Minnesota Senior Federation, and Paul Severance, founder of United Senior Action of Indiana, as co-chairs.
--The importance of access to prescription medicines as part of a regimen of critical health care is gaining increased attention from media. Reports are that the Associated Press is preparing a feature on the savings that could be provided for seniors if the Obama Administration acts to provide not only price negotiation for prescription medicines, but would support importation to provide even more options for America's elderly and additional competitive pressures that would lower prices.
--Hard-pressed local governments, facing fiscal crises are finding that there are alternatives to layoffs, cutting services or attempting to increase taxes through significant savings. One example is Montgomery County, NY which has saved more than half-a-million dollars since using the services of CanaRx, an internationally based prescription medicine plan developer and administrator offering access to maintenance medicines from Tier One Countries.
--A number of advocates to reduce prescription medicine prices through importation will assemble during the FamiliesUSA annual meeting in Washington, DC January 28-31. At that time, a number of meetings will be held with Congressmen and Congresswomen, and staffers.
--A number of contacts have already been made with staffs and Congressional-Senate offices to evaluate the support for co-sponsorships. With the new Democratic majority, odds of Pharma success in poison-pill provisions regarding certification by the Secretary of Health and Human Services, is lessened. Also, former Senator Tom Daschle (D-SD), selected by the Obama Administration for the Secretary of HHS, has been a suppporter of importation.
--Additionally, a number of contacts has been made with groups that have supported importation and access to safe, affordable prescription medicines in the past, as part of the Coalition building to work for success in the 111th Congress.