Monday, September 27, 2010

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.

Tuesday, September 21, 2010

Seizures of prescriptions represent broken promise of Obama Administration to support of personal importation of prescription medicines

A rash of seizures by the Food and Drug Administration of vital medicines from licensed, registered pharmacies in Tier One Countries is threatening the health of Americans by denying them their right to purchase safe, affordable medicines that are identical to those sold in the U.S., but at prices as much as 60 percent lower.

The FDA action breaks the promise made during the 2008 Presidential campaign by then-candidate Obama to provide access through personal importation of these medicines as a part a strategy of lowering prescription drug costs in the U.S.

When Obama was seeking the votes of America’s Seniors, their caregivers and families, he and others spoke frequently and with great conviction about their support of the right of individuals to purchase safe, affordable medicines from sources outside the U.S.

But, in September 2008, Dora Hughes of the Obama Campaign Staff sent up the first signals that the support was not as strong as Candidate Obama would have people believe when she was quoted as saying that there were problems with what is called reimportation.

(The term reimportation is misleading. Personal importation is more accurate as it best describes American citizens exercising their right to purchase the very same medicines that are priced at as much as 60 percent more in the U.S. than from pharmacies in Tier One Countries that meet or exceed standards of oversight of those in this country.)

Since then, the Obama Administration has engaged in a series of actions that indicate that it not only has no intention of carrying out its campaign pledge, but has even made arrangements and deals with the pharmaceutical industry that have helped boost the cost of medicines to such an extent that a growing number of Americans are finding drug prices to be a deterrent to their being able to buy and take their prescriptions.

· The deal with PhRMA in which the drug industry ‘agreed’ to lower prescription drug prices for drugs in the dreaded Doughnut Hole of Medicare Part D, only to raise prices at rates far exceeding inflation during the year before the price drop was to take place, is the prime example of the willingness of the Administration to sacrifice principle for process. Actually, PhRMA limited its ‘financial hit’ to $80 billion over ten years, a ‘hit’ that will almost certainly be outstripped by the industry’s price increases. The price increases are already eating up the $250 stipend paid to Seniors in the Doughnut Hole. In return, PhRMA pledged not to oppose the President’s signature legislation, the Patient Protection and Affordable Care Act.

· As a part of what many consider the quid pro quo for PhRMA’s pledge, the Administration kicked ‘reimportation’ of prescription medicines—and its primary supporter for many years, Senator Byron Dorgan (D-ND)—under the bus when FDA Commissioner Margaret A. Hamburg, in a letter to the Senate, warned that her agency was not able to guarantee that drug imports would not be counterfeited or contaminated. The Administration was silent about Commissioner Hamburg’s statement.

· There was speculation that the Administration had also pledged to continue to oppose personal importation as a part of the PhRMA deal. The stepped-up seizures and the Administration's coziness with a PhRMA-backed group, the Partnership for Safe Medicines (PSM), lends credibility to that concern. Consider this timeline:


05/2009: PSM opposes Reimportation... 09/18/2009: PSM says Search Engines promote illicit drugs...12/08//2009 : Commission Hamburg says ‘difficulties exist’ for safe reimportation , Dorgan Amendment fails...02/10/2010 : PSM applauds Google position on stopping Internet pay per click for Canadian pharmacies...06/22/: PSM applauds Administration position on ‘protection’ of intellectual property rights including drug manufacture...06/2010 : Commissioner Hamburg restates position about ‘difficulties’ with reimportation...06/2010: Senator Dorgan announces plans to introduce reimportation amendment to food safety legislation...07/29/2010: National Association of Chain Stores sends letter objecting to Dorgan amendment...09/14/2010: Generic group joins PSM...09/2010: PSM announces that Commissioner Hamburg to speak at Inaugural Conference on Counterfeit Medicines , sponsored by PSM...SEIZURES ACTIVITY PICKS UP IN AUGUST


PSM, which purports to seek an end to the danger of counterfeit medicines, a goal which we all share, is the proverbial sheep in wolf’s clothing—a PhRMA- backed organization with interlinking relationships to PhRMA among its Board members. Consider these links of the Board members:


Marvin D. Shepherd, Ph.D , Director, Center for Pharmacoeconomic Studies, College of Pharmacy, University of Texas-Austin , long-time record of opposition to personal importation, PhRMA links covered in previous blogs. http://rxforamericanhealth.blogspot.com/2009/07/time-for-critics-of-importation-to-look.html

Bryan A. Liang, Ph.D, M.D., J.D. , Executive Director, Institute of Health Law Studies, California Western School of Law Co-Director, San Diego Center for Patient Safety. See linkage to James N. Class, below

James N. Class, Ph.D Director, Global Public Policy, Merck & Co, Inc , Class is a member of the Institute of Health Law Studies at Case Western headed by Liang

Thomas T. Kubic , President and CEO, Pharmaceutical Security Institute, Composed of the security directors from 26 pharmaceutical manufacturers with business operations in more than 160 countries.

Scott A. LaGanga , Senior Director, Pharmaceutical Research and Manufacturers of America,

· While the latest round of seizures reflect a lesson learned by the FDA as it ‘softens’ its approach by posturing as the ‘protector’ of the patient that has ordered the medicine , it apparently doesn’t know much about formularies as one of the primary drugs seized is Lipitor, manufactured by Pfizer in Ireland for distribution and sale world-wide. But the highest-selling drug in the world is, according to the FDA, apparently a new drug with its safety and effectiveness in question (an excerpt from the FDA letter follows);

o ”According to the FDA’s ‘Procedures for Human Pharmaceutical Products Shipped through International Mail Facilities, it is a new drug because it is not generally recognized as safe and effective by experts and requires a prescription. It is an unapproved drug because there is no FDA approval of a new drug application on file for the product…” (emphasis mine)


· There is, of course, a prescription for the seized medicine. The FDA has admitted that it does not test the seized medications. The new letter says that the agency is not accusing the patient of a crime. What then is the basis of the seizure? The claim of acting as a protective measure simply dissipates in the light of the fact that by its action, the FDA is actually endangering the finances of the patient at best by denying them the right to purchase safe, affordable medicines.


At worst, by the denial of a vital medicine designed to protect the health of the patient, the FDA is endangering the health and well-being of the patient—this by an agency that is supposed to serve the public good. The Obama Administration should act on its election pledge to lower the prices of prescription medicines with a number of strategies, including the right of personal importation, and direct its appointees to act to stop the possible health-threatening seizures of vital medicines.


Commissioner Hamburg is widely recognized as a talented, intelligent professional with high standing in the medical community. Surely she can apply some of those talents to addressing what she perceives as ‘difficulties’ and work to deal with a problem that affects the very heart of our health care system—the highest drug prices in the world.