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.