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

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

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.

Pharmaceutical Industry is Biggest Defrauder of the Federal Government under the False Claims Act, Public Citizen Study finds

Publisher's Note: This article from Public Citizen illustrates the continuing questionable practices of the pharmaceutical industry and casts doubts on the veracity of the many organizations and individuals who act as fronts for it...and upon the judgement of the Obama Administration which has struck deals with Pharma and is prepared to accept its 'guidelines' on identification of bogus pharmacies, including the attempt to cast a net to snare legitimate on-line pharmacies offering Americans their only access to safe, affordable medicines.

WASHINGTON, D.C., January 2 , 2011 – The drug industry has now become the biggest defrauder of the federal government, as determined by payments it has made for violations of the False Claims Act (FCA), surpassing the defense industry, which had long been the leader, according to a new Public Citizen study.

The study found that pharmaceutical cases accounted for at least 25 percent of all federal FCA payouts over the past decade, compared with 11 percent by the defense industry.

The fraud results were a key finding from a Public Citizen analysis of all major pharmaceutical company civil and criminal settlements on the state and federal levels since 1991 and found that the frequency with which the pharmaceutical industry has allegedly violated federal and state laws has increased at an alarming rate. Of the 165 pharmaceutical industry settlements comprising $19.8 billion in penalties during the past 20 years, 73 percent of the settlements (121) and 75 percent of the dollar amount ($14.8 billion) have occurred during the past five years.

Many of the infractions, and the single largest category of financial penalties, stemmed from the practice of off-label promotion of pharmaceuticals – the illegal promotion of a drug for uses not approved by the Food and Drug Administration (FDA). Off-label promotion can be prosecuted as a criminal offense because of the potential for serious adverse health consequences to patients from such promotional activities. Another major category of federal financial penalties was purposely overcharging for drugs under various federal programs, which constitutes a violation of the FCA.

On the state level, the largest category of financial penalties has come from companies deliberately overcharging state health programs, such as Medicaid. Public Citizen’s study found this to be the most common category of violation among state settlements.

The increase in payments for fraud is likely attributable to drug companies engaging in more wrongdoing and better enforcement at the state and federal level, said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen.

“Desperate to maintain their high margin of profit in the face of a dwindling number of important new drugs, these figures show that the industry has engaged in such activities as dangerous, illegal promotion for unapproved uses of drugs and deliberately overcharging vital government health programs, such as Medicare and Medicaid,” said Wolfe. Wolfe compiled and analyzed the data with physicians from the Johns Hopkins General Preventive Medicine program, Drs. Sammy Almashat and Charles Preston, as well as Columbia University public health student Timothy Waterman, all of whom worked at Public Citizen.

Public Citizen’s study also found that more than one-half of the industry’s fines were paid by just a few companies – GlaxoSmithKline, Pfizer, Eli Lilly and Schering-Plough. These four companies accounted for more than half of all financial penalties over the past two decades, paying $10.5 billion in fines collectively. These pharmaceutical companies were among the largest in the world. The two largest criminal penalties ever assessed by the U.S. government against any companies were against Lilly ($515 million) and Pfizer ($1.2 billion), both in 2009.

To conduct the study, Public Citizen created a database of information about pharmaceutical companies’ civil and criminal settlements, including information about the type of alleged violation and the amount of money paid in settlements. This study is the first to attempt to document and analyze all major pharmaceutical company settlements with both federal and state governments, the authors said.

Nationally, former pharmaceutical company employees and other whistleblowers have been instrumental in bringing to light the most egregious violations; they have initiated the largest number of federal settlements in the past decade. The number of federal settlements arising from whistleblower cases has more than doubled over the past five years, yielding total payouts more than two and a half times higher than in the previous 15 years combined.

Needed remedies include imposing steeper financial penalties and criminally prosecuting company leadership, including jail sentences, if merited.

“The danger to public safety and loss of state and federal dollars that comes with these violations require a more robust response,” Wolfe said.

To read the full report, visit http://www.citizen.org/hrg1924.
###
Public Citizen is a nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.

Stop Pharma from denying access for Americans to safe, affordable prescriptions

If you agree with this position, write your Congressman or Senator to let them know of your support of the right of Americans to purchase safe, affordable—and vital—medicines from licensed, registered pharmacies in Tier One countries.

· 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 Canada and other 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 Canada and 22 other countries whose standards of oversight for safety and efficacy equal or exceed those of the U.S.

· While a rash of bogus pharmacies and counterfeit medicines has arisen on the Internet, legitimate on-line pharmacies have taken extraordinary steps to distinguish them 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 S 3804 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 S 3804 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 S 3804 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 S 3804, 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.

· We believe that Americans have the right to make personal healthcare decisions including the right to purchase safe, affordable medicines from licensed, registered pharmacies, and that they have the capability to make such informed decisions in a responsible manner, free of governmental interference, and that current efforts to define legitimate pharmacies as bogus is an attempt by the pharmaceutical industry to extend its influence to impose its predatory pricing practices upon American citizens with regard only for industry profits, not the health and well-being of American citizens.

If you agree with this position, write your Congressman or Senator to let them know of your support of the right of Americans to purchase safe, affordable—and vital—medicines from licensed, registered pharmacies in Tier One countries. We will be posting email addresses for the new session of Congress in early January 2011.

Pharma Interests attack Open Web in attempt to deter importation

Publisher of leading seniors’ web sites urges Congress clarify language of Anti-Counterfeiting proposal to prevent co-opting of Intent by pharmaceutical industry

The publisher of a leading informational site for America’s seniors, says that Congress must clarify the language of S. 3804, which is ostensibly designed to deal with the issue of intellectual property rights and counterfeit products sold in the U.S., to deter attempts by special interest organizations of the Pharmaceutical industry to co-opt the legislation to their own limited purposes and the detriment to health and savings for Americans.

Daniel Hines,. Publisher of www.TodaysSeniorsNetwork.com and http://RxforAmericanhealth.blogspot.com , says that the pharmaceutical industry is attempting to utilize the open-ended language of S.3804 as part of its latest tactics to prevent Americans from utilizing personal importation of vital and safe, affordable prescription medicines from licensed, registered pharmacies in countries whose standards meet or exceed those of the U.S. and the FDA.

Additionally, a growing number of legal sources is coming to view the enforcement provisions of S.3804 as an attempt to empower the Federal government to extend its ‘enforcement’ of ‘infringements’ upon intellectual property rights to web sites that the AG believes might contain materials that constitute such an ‘infringement’ by the shutting down of those domains.

“Pharma has long attempted to deny Seniors and other Americans access to these medicines through its extensive lobbying among elected officials and with appointed policy-makers, “ Hines says. “The many health and cost-saving benefits of Americans having the capability to exercise their right to make personal health care decisions through the purchase of safe, affordable medicines from licensed, registered pharmacies from 22 Tier One Countries, are evident and a matter of record.”

The reason for Pharma’s opposition to personal importation—ironically, importation of the very same medicines that they produce under FDA oversight and themselves sell in the U.S. —is that the imported medicines are priced at 40 to 60 percent less that the identical medicine in the U.S., Hines says.

“This record of savings, efficacy and health benefits, has been validated by the U.S. Congress on many votes in favor of personal importation, only to be turned aside because of parliamentary maneuvering of the interests of the pharmaceutical industry with the addition of a ‘personal certification’ requirement of the safety of imported medicines by the Secretary of Health and Human Services (HHS). No other Cabinet member is required to make such certification of products that are within their department’s jurisdiction.

Ironically, even though HHS Secretary Sebelius indicated her support of personal importation while Governor of Kansas by announcing the state’s affiliation with the ISaveRx program, the current FDA policy has been to not even consider how a policy favored by the President during his election campaign and the Secretary when she was Kansas Governor might be implemented. Instead, the emphasis has been upon policies supported by Pharma to focus on means of deterring Americans access to legitimate, vital medicines, especially through restrictions on the Internet.

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.

“But it has shown no interest in directing its vast resources to establishing a mechanism and framework that could address the best means of identifying legitimate, licensed pharmacies in Tier One countries and how to distinguish those legitimate on-line pharmacies from bogus operations.

He says that the legislation was approved by the Judiciary Committee during the Lame Duck Session of Congress. “The opportunity still exists for members of the Committee and Congress to allow public comment and hearings that would provide transparency into the deliberative process, thereby ensuring that S 3804 meets its stated purpose rather than rewarding the false claims of Pharma about the safety and efficacy of personal importation of prescription medicines.

“We urge the Committee members and other Senators and members of Congress to pay special attention to ensuring that the language in S.3804 encompasses the real goals of deterring copyright and intellectual property theft, as well as counterfeiting and that there be specific and clearly defined restrictions upon efforts by Pharma’s special interest groups to co-opt the intent of the bill.

“The health interests of large numbers of Americans should be of 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.

United States of Pharma (C): How Drug Companies abuse system, prevent us from getting safe, affordable medicines

Prescription medicine costs re-emerge as issue—The past few weeks have seen a rush of activity regarding prescription drug costs generally and moves within the Obama Administration and FDA with the pharmaceutical industry specifically.

Most troublesome are strategies to restrict access to imported medicines by the imposition of new legislation that would limit ‘infringement’ of claimed intellectual property rights of Pharma, even to the extent of shutting down Internet operations/web sites that support ‘activities’ that the government finds have aided such ‘infringement’ with support of a contrary position such as support of importation.

At the same time, there is an increasing realization that the price increases of Pharma are prompting increasing numbers of Americans to cut back on their prescriptions.

To gain a perspective on the breadth of the emerging debate, here are the issues in thumbnail:

· What is the impact of PhRMA’s ‘cost-cutting’ on its revenues? Bloomberg reports that the industry will see its revenues from the deal drop by less than one-half of one percent, and because it will receive as much as 32 million new customers under the provisions of Obamacare, the ‘deal’ was a significant win for Pharma. The article also points out that the deal helped Pharma avoid other actions such as importation of prescription drugs and Part D price negotiation.

· The failure of cutting the costs of the Part D Doughnut Hole—Because Pharma’s part of the deal with the Administration does not take effect until next year, it was able to initiate price increases of as much as 10 percent (reported on in earlier wraps) on brand name drugs—increases that are being paid for by Seniors and other Medicare beneficiaries. One perspective of the scope of the problem is offered in a NY Daily News story on how to cut costs for those in the Doughnut Hole.

· There is growing suspicion of the impact of the deal made with Pharma—The Washington Post reports many believe that Pharma will skirt the deal with the Administration with price increases.

· The Heritage Foundation reports that the Administration deal with Pharma might actually provide an excuse for Pharma to raise prices.

· Stories are beginning to appear about Americans turning to Canadian pharmacies to cut drug costs. The Dallas News reports on one Senior’s plight.

· The New York Times offers an indication of Pharma’s willingness to act with total disregard for law and ‘deals’ by its willingness to “…flout a federal law that requires them to provide the government with pricing data needed to calculate discounts on medications prescribed for poor people…”

· There are other ongoing examples of Pharma’s disregard for fairness and obeying the law:

o New Jersey Pharmaceutical Company Settles Medicaid Fraud Allegations for $2M

o In Hawaii, a leading newspaper is calling for making the terms of a settlement with Pharma public, saying that the public has a “strong interest” in making the terms public. A lawyer for an unnamed pharmaceutical company is saying they should be kept confidential.

· Increasing numbers of Americans are skimping on their prescription drugs due not only to drug costs, but because of moves by insurance companies to reduce costs—The Wall Street Journal reports on the impact of insurance companies increasing co-pays and higher deductibles—steps aimed at decreasing costs—leading to an increase of 55 percent of ‘abandonment’ of prescriptions—drugs ordered but not picked up by consumers.

· States continue to struggle with the impact of high drug prices—In North Dakota, the question of who should own a pharmacy is debated. The state statute reads that an in-state pharmacy must be majority-owned by licensed pharmacists, but some claim this restriction leads to higher prices.

· In light of stepped-up seizure activity by the FDA of imported medicines,, we entered a blog on the FDA actions and Pharma’s attempt to make the U.S. a safe haven for its predatory pricing. We also issued a release criticizing the seizures (The Inspectors making the seizures said Lipitor was a new, unregistered drug and was unsafe...so much for the rationale for seizures when the world's largest selling drug is seized on such a false claim..)

FDA in Pharma’s Pocket—Despite the record of Pharma misdeeds, of which only some are included above, the FDA actions with the Partnership for Safe Medicines , a PhRMA front group (reference blog mentioned above to understand PhRMA control of PSM) on a number of fronts is troublesome:

· FDA Commission Margaret Hamburg is the new Poster Girl for PhRMA. She spoke at the meeting sponsored by PSM on counterfeit medicines, then in a display that made her look more like a spokesperson for PhRMA than an FDA Commissioner, she conducted a Q-A session before a backdrop emblazoned with the logos of all of PhRMA’s members. A video of the Q-A session is available on the C-Span site.

Earlier I mentioned copyright ‘infringement’ as a new tactic by PhRMA and the FDA to attack importation:

o The Hatch-Leahy Act (proposed) is seemingly aimed primarily at counterfeit items such as music, movies, CDs, etc. But, it also includes the capability of being applied to a rationale for halting of personal importation, I believe.

o The White House ‘summoned’ a by-invitation only meeting for ICANN and other internet-related domain services to discuss ‘counterfeit’ products and sites that promote them, including ‘rogue pharmacies’ In an act of political courage, ICANN refused to attend the meeting..

o This did not stop Attorney General Eric Holder from ‘touching’ on ‘illegal web-based pharmacies; in a speech on opiate abuse. Note the linked article is on the PSM web site.

o Concurrently, stories are beginning to appear again about the lack of safety of ‘Canadian pharmacies.’ These are, of course, totally inaccurate since the safety and efficacy of prescription medicines from licensed, registered pharmacies in Tier One countries is based upon meeting standards that meet or exceed those of the U.S.

· In a bitter irony, Commissioner Hamburg, whose primary responsibility if the safety of foods and medicines, approves and supports the continued use of Avandia, making the U.S. the only country in the world where the sale of the drug is approved. Her rationale: It’s the only alternative for people with Type 2 Diabetes, so we are witnessing the spectacle of an FDA official who says that proven safe, affordable medicines from Tier One Countries are dangerous and the government must take actions to protect Americans from these ‘unsafe’ medicines, it is quite OK to put Diabetics at risk of heart attack or stroke. I shall be writing a blog on this.

How Pharma attempts to turn U.S. into ‘safe haven’—The United States of Pharma ©-- for predatory prescription prices by reducing rights of Americans

Publisher’s Note: Rights, Responsibility, Capability: For nearly eight years, I have been involved in work to promote the right of Americans to make personal health decisions to protect their health with the purchase of safe, affordable medicines from Tier One Countries. I believe that Americans have the right to make such decisions, while exercising their personal responsibility for good health, coupled with the inherent capability of Americans to make such decisions, free of artificial and incorrect ‘concerns’ about safety and efficacy that are really nothing more than a cover to protect the predatory pricing practices of the pharmaceutical industry, practices that unfortunately continue to be protected by elected officials and policy makers whose primary interest should be the protection of the health and well-being of American citizens. Instead, they unfortunately demonstrate their lack of faith in the capability of Americans to make decisions about their health. Because of that, in the next few weeks, I shall be presenting behind-the-scenes activities that almost certainly have adversely affected the health of untold numbers of Americans and made the country a ‘safe haven’ for Pharma pricing and practices. This first in the series is a broad look at the issue and how the pharmaceutical industry has co-opted the political process of this healthcare issue. The next post will deal with a failed attempt at cooperation with a major drug manufacturer to enlarge the discussion to focus on the healthcare benefits of a regimen of access to vital medicines—irrespective of source—as a crucial part of reducing healthcare costs.

Ever since the advent of the Internet helped make Americans aware that they were paying the highest prices in the world for their medications and that they could exercise their common sense to make responsible decisions about vital medicines to both save money and protect their health with purchases from mail order pharmacies via the Internet, the pharmaceutical industry has conducted what may be the most vigorous campaign by any industry group in our history to deny Americans their right to make their own health care decisions.

Its campaign—conducted by PhRMA, the industry trade group, an, d an untold number of the many fancifully name front groups it has funded (such as the Partnership for Safe Medications, LegitScripts, United Seniors Association, 60Plus, Center for Medicine in the Public Interest, to name a few)-- is a tragic textbook case study of how an industry whose primary concern should be the advancement of the health and well-being of Americans rather than profit, has spent millions of dollars to establish questionable relationships with policy makers and elected officials to set policies that ensure strategies that have denied large numbers of Americans access to the health benefits that could be made possible through access to safe, affordable medicines.

Ironically, the industry has been able to do this while it has been involved in massive wrong-doing of overpricing its medicines and defrauding millions upon millions of dollars from government programs such as Medicaid and Medicare. It has also spent millions upon millions of dollars for direct to consumer marketing (the U.S. is one of only two countries that allow such advertising).

It’s ‘gifts’ to physicians has, thankfully, been recognized as an attempt to ‘persuade’ what should be decisions based upon the needs of patients, not the value of the ‘gift’. It has foisted unsafe drugs upon an unsuspecting public. Merck recently was found liable for $250 million for the death of a patient in TX in 2001 after taking Vioxx, and that's only one example.

One would think that this record of misdeeds would generate a sense of righteous indignation among our Congressmen, Senators and the President.

Instead, pharmaceutical industry representatives are embraced by our President and Congressmen for ‘agreeing’ to charge 50 percent less for vital medicines sold to Seniors in the dreaded ‘Doughnut Hole’ within a year of the enactment of the Obama-Baucus healthcare legislation, afterwhich they embark upon a series of price increases that virtually ensure that the claimed savings will not only not exist for the Elderly in 2011, but that Pharma profits will be protected.

The latest example of how the pharmaceutical industry co-opts groups comes with the push for ‘safe prescription medicines’ by using antii-counterfeiting sentiment as included in the Hatch-Leahy legislation regarding ‘infringement’ of intellectual property rights.

Under the proposed bill, the U.S. Department of Justice would be empowered to initiate in rem civil action ( In rem specifies an action against a thing, property, or right, rather than a person) and is claime “… to protect the investment American companies make in developing brands and creating content and will protect the jobs associated with those investments.”

This is highly admirable. The theft of intellectual property is of serious concern. And, not surprisingly, I have received messages from music industry representatives who have urged that we express our support on various web sites.

The problem is that the proposed legislation might be seen as opening the door for infringement upon other claimed forms of intellectual property rights such as claiming that pharmaceutical manufacturers having the right to claim ‘infringement’ upon their ‘intellellctual property’ if a pharmacy from outside the U.S. sells a company’s medicines to someone in the U.S., even if it is the same medicine sold in the U.S. (at prices of as much as 60 to 80 percent more).

There is also the possibility that there could be grounds against a web site that practices its right of free speech in support of a position that is contrary to the Justice Department stance. Already the debate has begun with President Obama pledging support of free speech on the Internet, although there are many who question if this support is for domestic speech or if it is more of a statement directed to an international audience since the comments were made at a United Nations session .

While it might seem a ‘stretch’ from CDs and books or articles to prescription medicines, the pharmaceutical industry (Merck) did sue several Canadian pharmacies about five to six years ago on the grounds that its intellectual property rights had been violated claiming it has the exclusive right to determine where and how its products could be sold even though it had already sold the medicines to licensed, registered pharmacies.

While all of this is occurring, PhRMA and its front groups such as PSM , engage in a classic example of misdirection under the umbrella of the very real concern of counterfeit medicines, which we vigorously oppose.

I say ‘misdirection’ because PSM attempts to create a linkage between pharmacies in other countries that must meet or exceed the standards for U.S.-based pharmacies and those in Kenyna or other third-world countries that lack such oversight.

If PSM, and the FDA, which periodically seizes vital prescription medicines that have come from pharmacies in Tier One countries, with their high standards of oversight, and are the identical product to that sold at the corner pharmacy, are concerned that such medicines are either not safe or counterfeit, they should provide the evidence that would validate their claims and actions. If they fail to do so, the FDA should stop the seizures and follow the will of the U.S. Senate when it voted overwhelmingly to halt seizures by Homeland Security. The FDA denied any role in the seizures, although Homeland Security said it was acting in collusion with the FDA.

They should answer the question about how many of the counterfeit drugs being seized are from licensed, legitimate pharmacies in Tier One Countries, and provide evidence of what it is that make the medicines ‘counterfeit’.

It is not adequate merely to point to a labeling difference that is based upon the requirements of the country of origin when the medicines are the same brand-name medicines produced at FDA-inspected sites. And, someone should let FDA inspectors and the U.S. Post Office know that Liptor is not a new, unregistered drug.

It is ironic that an Administration that said, if elected, it would support the rights of Americans to purchase medicines from outside the U.S. should now say there are difficulties in ensuring safety.

Perhaps the statement is more understandable as a reflection of the capability of the FDA than the safety and efficacy of imported medicines from Tier One countries since this is an agency that hasn’t been able to protect Americans from domestic products such as contaminated peanuts, eggs and, in a case that illustrates its gap in applying protect standards as compared to other countries, continues to allow the sale of Avandia, a drug for Diabetes that has been banned in the European Community.

The FDA solution: limit the use of Avandia only to “new US patients with type 2 diabetes only if they are unable to control their glucose levels through other medications.”

Ironically, FDA Commissioner Margaret Hamburg, who has claimed that there are ‘difficulties’ in ensuring the safety of legitimate and safe, effective medicines imported into the U.S. has apparently found a way to determine that Avandia can be justified, saying "The FDA is taking this action today to protect patients, after a careful effort to weigh benefits and risks,"

If only she would apply the same standards to the needs of Americans to access to vital medicines about which there is no question of safety, efficacy or price.