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Pharma practices ‘disingenuous connectivity’ in attacks upon personal importation

 Pharma, and its trade group PhRMA, are employing a strategy that is best described as ‘disingenuous connectivity’ in its latest strategies against personal importation of prescription medicines.

The strategy-- attempting to remove itself as the focus of attacks upon personal importation of safe, affordable medicines, from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy for prescription medicines meet or exceed those of the US. 

Why does this constitute being disingeous?  Let's look at the Dictionary definition:

‘Witholding known information or giving a false impression of sincerity or simplicity’’. 

 This is what Pharma is doing in establishing relationships and connections with  erstwhile and commendable interest groups to persuade them to adopt the admirable goal of  prescription drug safety as a part of their mission, but one in which any imported medicines are by definition of being imported are, in and of themselves, ‘unsafe’.

 Some examples:  The Institute of Medicine,   a national Non-Governmental Organization designed to provide national advice on health and medical issues and to develop programs for  patient safety, have, in response to a request from the Food and Drug Administration  for a study on drug safety issued a statement calling for increased tracking and tracing of the worldwide pharmaceutical chain of custody.

 The IOM statement does base its appeal on recognition of the problems of admittedly bogus pharmacies and counterfeit medicines.  It is disturbing in other ways, however,  not the least of which is that  IOM has dropped the use of the word ‘counterfeit’ to describe fake medicines, choosing instead to restrict the term to encroachment of intellectual property rights, a Pharma goal in its failed PIPA and SOPA pushes. 

 Another  example:  In a recent article in the Journal of Nursing, the nurse community is urged to assist in counseling patients on drug safety, using standards that limit the application of a ‘safe pharmacy’ or source of personally imported medicines to only those in the US.

 The FDA is a major player in this effort.  Its new web site ‘identifying’  what it describes as ‘unsafe’ pharmacies uses the VIPPS program as a resource, an embrace that reflects the success  of the  National Boards of Pharmacy Verified Internet Pharmacy Practice Sites (VIPPS) program and opponents of personal importation to provide what might be a ‘gateway’ service designed to allow FDA and Pharma to claim, because there continues to be legislation empowering the FDA to contract selected services to privately sourced, third-party groups in the private sector to conduct safety oversight that normally would be a part of the FDA responsibility within the limits determined by Congress.

 As to prove the case, the Journal of Nursing refers nurses and patients to the FDA site and the VIPPS program as the ‘standards’ for safety.

  To imply that all medicines from licensed, registered pharmacies outside the US are unsafe does not stand in the light of facts. Many countries, especially those in Tier One Countries do have excellent standards of safety.  Add to this that virtually all prescription medicines sold in the US are manufactured at plants outside this country, meaning that even those medicines sold in NABP pharmacies, are likely imported into the US.

 The target of these programs is not prescription medicines that might be ordered from clearly identifiable bogus pharmacies on the Internet, but those safe sources from outside the US that provide as many as two million Americans access to safe, affordable prescription medicines that would otherwise be denied to them because of the predatory pricing practices of Pharma that have made the US a safe haven for the highest prescription drug prices in the industrialized world.

 No one disputes the need to ensure that Americans are made aware of the potential danger of bogus pharmacies, and providing Americans with the tools to identify such pharmacies. There are ample guidelines on identifying guidelines to ensure safety based on more than a decade of safe use of personally imported prescription medicines.

  For more than 12 years, seniors’ advocacy groups and others have made the case that access to safe, affordable medicines via personal importation is a matter of fact.

  Supporters of personal importation have published stories, guidelines, and have developed materials to help identify the validity of a pharmacy. The US Congress has repeatedly passed legislation in support of personal importation only to see it turned aside by ‘poison pill’ amendments brought forth by Congressional supporters of Pharma. 

 Even the FDA has taken actions that validate the claims of supporters of personal importation that the regulatory agencies of Tier One Countries meet or exceed those of the US and should therefore be the basis of approval for personally imported medicines, by moving to allow a form of reciprocity in the oversight and manufacture of ingredients for prescription medicines by regulatory agencies in countries outside the US.

 This leads to the simple question:  If reciprocity is ‘doable’ in the case of ingredient manufacture, why is it not able to be extended to personal importation? 

 The answer:  this just another example of the disingenuous strategies of Pharma and others.

 There are more:

 PhRMA has launched a series of efforts to attain goals that it was denied by the legislative process, including what is cited as patent and trademark protection but really was nothing more than attempting to co-opt legislation by shaping it in a manner that reflected its goals of deterring personal importation. 

 The examples below amplify the case that Pharma is indeed engaged in a full scale attack upon personal importation with no concern for the vital lifeline it provides to untold numbers of Americans, or the fiscal impact to citizens being denied access to affordable medicines:

·         The drafting of a bill by the Senate Health Committee and House Energy and Commerce Committee in October 2012, written by staff members, free of any input from stakeholders. The ‘draft’ established the framework for the empowering of the FDA to enter into third-party relationships with the private sector granting the authority mentioned in the paragraph above.  The 118-page draft was not even submitted for consideration.  The question must be asked: Why not?  Is it still in someone’s desk drawer waiting to be pulled out for introduction in the 113^th Congress, free of any opportunity for input from stakeholders? The language also focuses on ‘potentially’ unsafe medicines, a particularly troublesome term since there are no standards of what constitutes ‘potentially’ except for several mentions of ‘misbranded’ (read personally imported) medicines.

·         The FDA Reauthorization bill (PDUFA) calls for Rules Promulgation in the next two years.  Section 708 empowers the seizure of medicines dispensed by pharmacies in countries outside the US for Americans’ use by granting the power of seizure to Customs, Homeland Security, and Border Agents. Questions that must be asked and answered include but are not limited to:

o     When will FDA communicate the schedule on Rules Promulgation;

o    How will it ensure that all persons and groups desiring to make comments are notified?

o      The challenge:  the language as written gives authority for the Secretaries of HHS and Homeland Security to make seizures by Customs  and destroy them.  In a disturbing aside, Senator Bill Nelson (D-FL) , chair of the Senate Select Committee on Aging, and a supporter of personal importation, tells a senior advocate in Florida that he believes the action in 2007 when he and Senator David Vitter (R-LA) led legislation that ended FDA-Customs collusion resulting in seizures of personally imported medicines , is a precedent that will preclude such action now.  Unfortunately, he is incorrect.

·         FDA launches a website in an effort to ‘identify’ what it describes as ‘safe pharmacies’,  all within the US, again using the VIPPS model;

·         The Center for Safe Internet Pharmacies ‘launches’, a year after its founding.  The timing of the launch seems to be a part of a communications effort to attain a critical mass to determine the ‘message’ that the definition of safe pharmacies of safe pharmacies is applicable only to those in the US.  Again, the VIPPS model comes into play;

·         FDA issues a series of news releases, including statements from FDA Commission Margaret Hamburg, about the need for new initiatives in the chain of custody to guarantee the safety of the prescription medicine supply.  This comes only months after more than 60 people dying from unsafe medicines from a Massachusetts compounding pharmacy.

·         The problem with the counterfeit Avastin (bogus?) continues to be a mainstay of FDA releases.  The identification of potentially dangerous medicines is a commendable goal and important to protecting Americans, but there is no record of anyone becoming ill of dying from taking the Avastin.  The Federal government has commendably been diligent in its prosecution of offenders, many of whom are physicians.

·         The President of Eli Lily, angered by the refusal of Canadian authorities to approve a patent, suggests in a prepared statement that Lily is granted a degree of sovereignty equal to that of Canada due to the North American Free Trade Agreement, and , that companies such as Lily (and other Pharma companies?) have such a standing in not only NAFTA, but future trade agreements. What does this say about the sovereignty of a country like Canada...or even the US...and its authority to conduct its governmental functions?

·         PhRMA apparently has returned to the issue of controlling the Internet. But, apparently burned by its SOPA debacle, this time,  Pharma has the NABP acting on its behalf as it seeks a new domain designation for .pharmacy.  The .pharmacy designation would be specific for US-based pharmacies only, would disable Americans from having access to Internet pharmacies in other countries (including Canada), and would utilize, yes, the VIPPS list to determine approved pharmacies, in effect granting PhRMA the victory it was denied in the PIPA and SOPA battles.  Of interest, in its application for the .pharmacy designation, NABP declares that FDA, Pharma, other groups will conduct a vigorous communications and educational campaign on the significance of the new domain designation.  This is a move to encroach upon the freedom of the Internet and to attempt to utilize  .pharmacy for the special interests of NABP and Pharma.  It should receive the same vigorous opposition as the SOPA boycott.

Look for the pattern to hold true. The FDA is faced with budget cuts, plus Sequestration, Pharma is desperate to circumvent the openness of the legislative process with its demands for hearings, testimony, and, public statements from stake holders.  

 The goal is the silencing of seniors’ advocates and others who support the benefits that access to such a vital lifeline and savings from prescription medicines offered by personal importation. 

 

Pharma and its allies are opting for passage of administrative rules that the rules makers will adopt citing that they either has the power to make such decisions, and which it will attempt to validate through the passage of vaguely written ‘drafts’ crafted behind closed doors.

  It provides us with a new phrase to describe what we are witnessing:  disingenuous connectivity.  It is time for Congress to pull the plug.

Helping Doctors Communicate Better When Prescribing Meds

Newswise — When it comes to prescribing medications to their patients, physicians could use a dose of extra training, according to a new study led by a UCLA researcher.

In previous studies, Dr. Derjung Tarn and her colleagues found that when doctors prescribed medicines, the information they provided to patients was spotty at best, they rarely addressed the cost of medications and they didn't adequately monitor their patients' medication adherence.

The logical next step, Tarn said, was to devise an intervention aimed at improving how physicians communicate to their patients five basic facts about a prescribed medication: the medication's name, its purpose, the directions for its use, the duration of use and the potential side effects. 

And it appears to have worked.

Tarn and her co-researchers found that physicians who completed the training demonstrated a significant improvement in how they communicated this crucial information. 

Compared to a control group that didn't receive the training, these doctors discussed at least one additional topic out of the five — and they sometimes went beyond the basics, touching on other pertinent facts about medications that are important for patients to know.

The intervention is described in the January issue of the journal Annals of Family Medicine.

"We were pleasantly surprised to see that a simple intervention was effective in improving the content of discussions," said Tarn, the study's lead author and assistant professor of family medicine at the David Geffen School of Medicine at UCLA.

The researchers conducted a controlled clinical trial between February 2009 and February 2010 with 27 primary care physicians and 256 patients. 

The training consisted of a one-hour interactive educational session that encouraged doctors to communicate the five basic facts about prescribed medications. 

The researchers also gave the participating patients a flier listing the five facts. In addition, they recorded the audio of the physician–patient interactions. 

The success of the physicians' communication of the key facts to patients was measured using the Medication Communication Index, or MCI.

The researchers found that the mean MCI for the physicians in the intervention group was 3.95 out of five, compared with 2.86 for those physicians who didn't receive the training. The intervention-group doctors also received higher ratings from their patients on how they communicated information about medications than did the physicians in the control group.

And, significantly, the training resulted in more than just better communication about the medications the physicians prescribed, according to the study.

"Interestingly, higher MCI scores also were associated with more reports of communication about topics not directly included in the intervention," the researchers write.

 "For example, the intervention encouraged physicians to discuss potential medication side effects with patients, but patients also reported better communication about the risk of experiencing side effects and what to do if side effects occurred."

The study has some limitations. Patients were predominantly white, most had at least some college education, and there were more Hispanics than African Americans. 

Also, having an audio recorder in the examination room may have enhanced communication for physicians in the intervention group more than for those in the control group, who were unaware of what the researchers were studying. In addition, the researchers didn't examine the doctors' style of communication, and they don't know if any additional time spent talking about new prescriptions might have detracted from conversations about other topics.

Still, the study suggests "that a brief, practical intervention can improve physician communication about newly prescribed medications in ways that affect patients," the researchers write. "The intervention should be tested for its clinical impact."

Tarn's co-researchers on the study were Chi-hong Tseng and Neil S. Wenger of UCLA, Debora A. Paterniti of UC Davis, and Deborah K. Orosz of Harvard University.

A grant from the National Institute on Aging (5K12AG001004) funded the study.

The UCLA Department of Family Medicine provides comprehensive primary care to entire families, from newborns to seniors. It provides low-risk obstetrical services and prenatal and inpatient care at UCLA Medical Center, Santa Monica, and outpatient care at the University Family Health Center in Santa Monica and the Mid-Valley Family Health Center, located in a Los Angeles County Health Center in Van Nuys, Calif. The department is also a leader in family medicine education, for both medical students and residents, and houses a significant research unit focusing on health care disparities among immigrant families and minority communities and other underserved populations in Los Angeles and California.

Action Alert: Congressional Action needed to prevent unfair seizures of safe, affordable medicines

As the 112^th Congress concludes its business and we prepare for the launch of the 113^th Congress, it is appropriate to call attention to one of the continuing major drivers of healthcare costs—the fact that Americans pay the highest prices for prescription medicines in the world.

It is these prices that have led millions of Americans to turn to personal importation of safe, affordable medicines from licensed, reputable pharmacies in Tier One Countries that have standards of efficacy and safety that meet or exceed those of the United States.

Many members of Congress have repeatedly recognized the importance of this lifeline to vital medicines for Americans by its support of personal importation.  Unfortunately, even when legislation to facilitate personal importation was passed,  Pharma-backed groups of Senators and Representatives thwarted the will of Congress and the American public by the addition of ‘poison pill’ amendments requiring ‘certification’ of each and every imported medicine by the Secretary of Health and Human Services (HHS).

In 2012, Pharma stepped up its activities to curtail the right and ability of Americans to engage in personal importation of their medicines with such legislation as the Protect Intellectual Property Act (PIPA) and the Stop Online Piracy Act (SOPA) , both of which would have given Pharma intellectual property rights that would have branded all imports as ‘counterfeit—ironically, including some of the very same medicines manufactured by Pharma members outside the United States and sold in this country.  

Fortunately, these bills were turned aside , the SOPA bill being particularly significant because it actually led to an Internet ‘blackout,’ a recognition of the onerous provisions of the legislation that would infringe upon a number of American rights.

However, with the passage of the PDUFA legislation—considered a ‘must pass’ piece of legislation to allow the Food and Drug Administration (FDA) to conduct its operations, Pharma again saw an opportunity—Section 708 which unfairly and inaccurately portrays personal importation of medicines from reputable pharmacies as being one and the same with the many bogus pharmacies selling unsafe, counterfeit medicines. A summary of our concerns follows:

a.     In 2006, a bi-partisan effort stopped Customs from seizing vital medicines personally imported by Seniors and others.   Seniors personally importing their medicines had been coerced to sign letters acknowledging their guilt in violating US law, and agreeing that the letter could be used against them in criminal prosecution if they (the Seniors) continued to practice personal importation. Congress found this unacceptable.

b.    We fear there may be some confusion about the actions taken in 2006 to block arbitrary seizures in response to such an abuse of power by Customs and the FDA.  It has come to our attention that there are those supporters of personal importation in Congress who seem to believe that the previous legislation will prevent such arbitrary seizures.  To them, we voice our gratitude for their past support.  However, we must caution that they do not confuse actions taken in 2006 as being binding upon Section 708. 

c.     Section 708 is different. It allows the Secretaries of HHS and Homeland Security to arbitrarily make seizures of medicines valued at $2500 or less if they are deemed to be potentially dangerous to Americans’ health. Unfortunately, this highly commendable goal has been co-opted by Pharma to be likely construed to extend to seizures of legitimate, safe medications.

d.    While the House version of PDUFA did not include any process for due process review, the Senate Leadership was able to get such a provision in the final bill. The following describes our understanding of the provisions:

                                          i.    From the viewpoint of personal importation the structure of the review is based upon an individual initiating a request for a review within 30 days.

                                         ii.    If there is no appeal, the seized medicines are subject to destruction.

                                        iii.    If there is an appeal, and it is not upheld, the individual making the appeal is liable for any costs incurred by the Government during the appeal process.

e.     The authority to make seizures is granted to a wide number of individual Customs agents.

f.     The reasons for seizures include, but are not limited to : Safety, unregistered medicine, new non-approved medicine lacking FDA review/approval (this would immediately make all personally imported medicines subject to seizure since they are approved by the regulatory agency of the country of origin), misbranding (this could include medicines identical to those sold in the US being subject to seizure because of labeling requirements of the country of origin.)

II.             It is our belief that the intent of the legislation as written is evident, creating an authority to grant seizure powers not only of bogus , dangerous and counterfeit drugs, but to expand the scope to seize vital medicines personally imported from sources outside the United States that have a proven record of safety and efficacy.

III.            When the bill was being considered, we made contact with staff on the Senate Health Committee, and were told by Majority Staff that this was not the ‘intent’ of the bill, and that Senate Majority leadership, notably Senator Harkin, was committed to the concept of personal importation of vital medicines, seeking assurances from the FDA that personally imported medicines were not the ‘target’ of the Section.

a.     Significantly, however, when asked further, Staff said that the assurances given to the Senator by FDA were adequate. We fear this might be the impression given to Congressional supporters

b.    Our review of Section 708 has not given us any reason to believe that such good will or intent without being addressed specifically in the legislative language, will prevent unwarranted seizures from occurring, or that individuals—especially seniors—will be able to navigate the complexities of the appeals process and face the risk of the potential costs of an appeal.

In summary, we believe that (a) Section 708 is written in such a manner as to enable arbitrary seizures of legitimate, safe, affordable , and vital medicines that provide a life-line to untold numbers of Americans (b) that even with the stated intent of supporters of personal importation that such seizures will not occur, without specific language excluding such seizures, and that the section , as written, leaves no room for interpretation to the contrary (c) our understanding of the provision is that there is not such exception in the bill.

The result will be that untold numbers of Americans will be forced to either pay higher costs for the very same medicines denied by the seizures, or more tragically imperil their health and well-being by not purchasing vital medicines.  The consequences will be tragic.

That is why we call upon Congress to be alert to what will admittedly be unintended consequences of actions that, on the surface, appear to have merit, but really are nothing more than yet another effort by Pharma-driven forces to solidify the United States as a safe haven for the highest prescription medicine prices in the world, and a major driver of the continuing rise in healthcare costs.

Thank you for your consideration of this letter.

Sincerely,

Daniel Hines

Daniel Hines

Publisher

www.TodaysSeniorsNetwork.com

TodaysSeniorsNetwork is comprised of www.TodaysSeniorsNetwork.com, a leading informational website for the challenges and opportunities of dealing with issues facing an Aging America attracting more than two million visitors annually across the nation, http://RxforAmericanHealth.blogspot.com, www.BoomersNewsOnline.com, and www.RxforAmericanHealth.com .

53 Oak Hill Drive, Ellisville, Missouri, 63021

Phone: 636.399.2849  Fax:  636.386.5904  e-mail: TodaysSeniorsNet@sbcglobal.net

Publisher of leading informational website for Seniors urges FDA to extend its recognition of the importance of ‘reciprocity’ in prescription drug manufacture to personal importation

St. Louis, October 8, 2012—The publisher of www.TodaysSeniorsNetwork.com, America’s leading informational website for issues affecting an aging America, says that the Food and Drug Administration (FDA) should extend its recently enacted policy of reciprocity with other countries to improve the safety of prescription drug ingredients manufactured in those countries for export to the U.S  to personal importation by Americans of medicines produced in those countries.

Daniel Hines noted that virtually all medicines sold in the US are manufactured outside of this country, and that access to safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One countries—those with standards of efficacy and oversight that meet or exceed those of the U.S.—provides the only relief for vast numbers of Americans who must either pay the highest costs for prescription medicines in the world, or choose to do without their vital, often life-saving medicines.

“The US is a safe-haven for the highest prescription medicine prices in the world, which is the reason that millions of Americans have turned to personal importation as a vital lifeline to their medicines—the very same medicines sold in the US at prices as much as 60 percent higher,” Hines explains.

“The actions of the FDA to establish reciprocity with regulatory agencies in countries outside the U.S. is an admission by the FDA that such cooperative arrangements can be accepted as providing the oversight that will validate the safety and efficacy of not only ingredient manufacture but of pharmacies, as so many advocates on behalf of personal importation have urged,” Hines says.

 “The problem is that, by confusing in the minds of the American public, bogus pharmacies with personal importation that has a proven record of safety and efficacy built by providing vital medicines to Americans for many years there could be unintended consequences adversely affecting the health and well-being of millions of Americans.”

While lauding the stated intent of a new FDA website ostensibly designed to help patients identify bogus, illegal pharmacies issuing counterfeit medicines as “an admirable goal”, he notes that “by limiting its ‘acceptable’ guidelines to domestic pharmacies, the FDA has missed a tremendous opportunity to extend its earlier announced policy of reciprocity and cooperation with regulatory agencies in other countries to improving competition, price-relief and enhanced health for Americans.

“In a recent interview, a Consumer Reports spokesperson described bogus pharmacies as being ‘like gopher holes that pop up everywhere even after being shut down.’

“That is why we urge the FDA to recognize that it might adversely affect legitimate and safe sources of medicines, forcing untold numbers of Americans to either curtail their vital medicines because they are unaffordable in the US—or, more troublesome,  leaving only bogus pharmacies to which unknowing patients might unwittingly turn.

 “The result with be an endangerment of the health and well-being of huge numbers of Americans. And therein lies the unintended consequences in which good motives go wrong, “ Hines says.

He identifies three steps that the FDA should take to remedy this dilemma:

·         The Secretary of Health and Human Services should direct the FDA to extend its policy of reciprocity regarding manufacture of ingredients and medicines with regulatory agencies of other countries by exploration of processes to identify those pharmacies that are licensed and reputable;

·         In light of repeated favorable votes in favor of personal importation, Congress should also direct that the FDA as a matter of public policy extend the policy of reciprocity to personal importation;

·         The FDA should clearly identify to Congress and the American public clearly identifiable bogus pharmacies, and its strategies to deter their access to selling counterfeit medicines;

 “Such actions will be a clear sign that the health and well-being of Americans is a primary goal of the FDA,” Hines concludes.  “It will also be a clear signal to Pharma that the FDA recognizes that the cost of prescription medicines in the US is a major driver of healthcare costs, and without clarification of the beneficial impact of personal importation upon American’s physical and financial health, the limitations of the new website will indeed have unintended and adverse consequences.”

Authors Dispute “Innovation Crisis” Among Pharmaceutical Companies

Publisher's Note: One of the claims of the Pharmaceutical Industry in its attempts to deter the rights of Americans to have access to safe, affordable brand-name prescription medicines from pharmacies in Tier One Countries is that personal importation would damage the ability of Pharma to engage in the Research and Development of new, innovative prescription medicines.  The following article from the British Medical Journal shows the fallacy of that stance.

Newswise —– A newly published article in the British Medical Journal disputes the widely held belief that profits at large pharmaceutical companies will plummet as the companies face a “patent cliff” when their exclusive rights expire on several blockbuster drugs. Co-authors Donald Light, PhD, of the University of Medicine and Dentistry of New Jersey-School of Osteopathic Medicine, and Dr. Joel Lexchin of the University of York (Toronto) argue that a “hidden business model” provides major pharmaceutical companies with a solid cushion of steady profits from patent-protected minor variations to their existing drugs.

“Most research and development at large pharmaceutical companies is directed at developing clinically minor drugs rather than finding better drugs for unmet needs,” said Light, who is also a Fellow at the Safra Center for Ethics at Harvard University. “Independent assessments indicate that 80 percent of increased costs paid by employers and insurers for pharmaceuticals is wasted on these ‘new’ drugs that can command higher prices under government patent protections even though they provide little or no benefit over existing medications.”

The authors say claims of an “innovation crisis” in the pharmaceutical industry are a myth arising from media reports of a roughly decade-long decline in the discovery of new molecular entities (NMEs). They cite industry studies to support that conclusion. The Food and Drug Administration defines an NME as “an active ingredient that has never before been marketed in the United States in any form.” According to the article by Light and Lexchin, the “crisis” simply represents a return from an unusual spike during the mid-1990s to the long term average of 15 to 25 NMEs per year.

“Companies are, of course, delighted when research breakthroughs occur, but don’t depend on them,” Light explained. “Instead they focus on promoting minor variations, spending 19 times as much on their marketing efforts as they do on basic research to discover new molecules.”

The resultant sales of these “minor” drugs – some of which become market blockbusters – offset the ups and downs of drugs coming off patents, the authors note. They point to the example of Pfizer, which lost market exclusivity for Lipitor and other major sellers in 2011, but still maintained steady revenues and saw net income increase by 21 percent over the previous year.

The University of Medicine and Dentistry of New Jersey (UMDNJ) is New Jersey’s only health sciences university with more than 6,000 students on five campuses attending the state's three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and New Jersey’s only school of public health. UMDNJ operates University Hospital, a Level I Trauma Center in Newark, and University Behavioral HealthCare, which provides a continuum of healthcare services with multiple locations throughout the state.

Why 'we get it' about personal importation

 In a news story about the launch of the Center for Safe Internet Pharmacies (CSIP), the lead in Fierce Pharma Manufacturing, a well-respected news email about the pharmaceutical industry, noted that  “An organization set up lastyear by some of the largest Internet and credit card companies to fight the  scourge of illegal pharmacies selling counterfeit drugs thinks consumers just don't get it.”

Having had more than five decades of experience in communications, and having worked for 12 years on behalf of the right of Americans to engage in personal importation of safe, affordable brand-name medicine from Tier One countries, whose standards of safety and efficacy meet or exceed those of the U.S, I had a sense of, as Yogi Berra used to say , “Dejavu all over again” as I read the statement.

The comment is one that I have heard many times from smug Beltway personalities who believe that Americans outside the Beltway simply lack the intelligence, common-sense and ability to act in a responsible manner to understand what policy-makers don’t, i.e., that personal importation is still the best option available to curtail Pharma (the industry) and PhRMA (its trade association) from making the U.S. even more of a safe haven for the highest prescription medicine prices in the world.

My favorite example was some time ago at a meeting of Former Speaker of the House (and later failed GOP Presidential candidate) Newt Gingrich’s ambitious Center for Health Transformation start-up in Missouri.

After the meeting, I asked his Chief of Staff about the role of personal importation and why the group did not support it as a means of deterring the major price driver of health care costs in the U.S.—rising, unaffordable prescription medicine costs. 

She smiled at me and answered, very condescendingly:  “We don’t want our poor seniors dying like all those pets whose food was contaminated by tainted ingredients from Chinese plants.”

My response: “Do I look like I fell off the turnip truck yesterday?  I asked you a legitimate question about healthcare policy and you talk to me about dog food—which, by the way, many seniors have eaten because they couldn’t afford their medicines!”

She walked away, never to be seen again (at least by me).

But, her spirit, like Marley's ghost , still wanders the earth.  The opening paragraph from the Fierce Pharma Manufacturing article was its latest incarnation.

I must point out that I am not critical of FPM since I am sure its comment merely reflected the fallacy of Pharma’s claims about the ability of Americans to act in a responsible manner when it comes to distinguishing clearly bogus sources of medicines from legitimate sources.

And, despite what the source of the comment about Americans “not getting it,”  I want to assure CISP that, yes we do:

• ·         We get it that prescription drug prices in the U.S. are the highest in the world, as much as 60 percent more than the same drug in Tier One Countries;

• ·         We get it that the medicines that PhRMA would deny access to are the very samemedicines manufactured in FDA-approved facilities, usually in plants outside the U.S.  and then given a different label to meet U.S. requirements (language, etc.) to be sold at tremendous markups to U.S. citizens;

• ·         We get it that PhRMA has an undue and troubling influence in healthcare policy, to the extent of dictating policy behind closed-doors to even the President of the United States;

• ·         We get it that dozens of members of the House of Representatives and the U.S. Senate receive millions of dollars from the pharmaceutical industry;

• ·         We get it that it was the necessity of untold numbers of Americans not being able to afford their prescription medicines more than 12 years ago that led to bustrips into Canada where suddenly Grandma became a ‘drug smuggler’ bringing back safe, affordable medicines from Canadian pharmacies, a situation that led to the rise of Canadian pharmacies establishing the online pharmacy business;

• ·         We get it that the answer was a flawed Part D Prescription Drug program in which seniors had to pay for insurance, pay high deductibles, and then after receiving their benefit, were forced into the so-called ‘Doughnut Hole’ in which they had to pay again for their medicines PLUS paying for their insurance ‘coverage,’ all thanks to the last-second efforts of Rep. Billy Tauzin (D-LA 3) to insertprovisions favorable to and dictated by PhRMA and its members (His reward?  He resigned from Congress and accepted the role of the head of PhRMA at a salary of $2 million per year.  Now, what do you think he ever did that made him worth that much to the industry?);

• ·         We get it the Pharmaceutical industry is considered by many the most corrupt inthe U.S.

• ·         We get it that as the industry claims to tout safety, many of its leading members continue to be found guilty of unsafe practices.  The most recent notable example is the travails of GlaxoSmithKline (GSK), which settled a Department of Justice action for  $3 BILLION!  (For the sake of transparency, at the above referred-to meeting of Newt Gingrich, I met with a director of state legislation for GSK who expressed an interest in outreach to seniors and establishing communications on the role of personal importation. We exchanged several emails regarding how that might be accomplished, since I believed that expanded personal importation could actually be of benefit to Americans by lowering prices, with the expanded use of affordable medicines by Americans actually being beneficial to the industry itself.  Needless to say, the conversations went nowhere, because, as my contact noted, ‘I had said some pretty rough things’ about industry practices. Based on the recent DOJ experience, perhaps GSK should have listened to me.)

• ·         We get it that the FDA has been charged by many as being instrumental in the shortage of vital medicines that has led to opening new opportunities for gaps in the worldwide supply chain to be exploited by counterfeiters.  (Ironically, the latest example of this, the entry of counterfeit Avastin, a cancer-treating drug, into the American supply, actually was detected and uncovered.  The leakage did not involve an internet pharmacy, although the wholesale operations of Canada Drugs, a leading Canadian internet pharmacy, were involved, and opponents have attempted to seize the situation to disparage the ability to guarantee the safety and efficacy of personally imported medicines.)

• ·         Weget it that safety is of primary importance, and that geography does notguarantee safety for those such as the Kansas City pharmacist, who was licensedby his state Board of Pharmacy, diluted vital cancer medicines for years beforebeing discovered in 2001;

• ·         Weget it that  Pharma’s hands are not ‘clean’in such matters.  In 2011, the offending pharmacist had a $2.2 billion judgment against him, and, significantly, EliLilly and Bristol-Myers Squibb, settled charges that they were negligent out of court;

• ·         We get it that the FDA has for years worked to scare Americans either by the use of the intimidation of seniors such as was done in the infamous use of Customs to seize medicines and then demand that the elderly sign letters admitting totheir ‘guilt’ and pledging to not engage in personal importation again, and now, with the launch of CSIP, a ‘public service announcement’ in which a youthful caregiver is concerned that prescription medicines ordered on the internet might kill Grandfather unless they are from a pharmacy ‘approved’ by CSIP;

• ·         We get it that responsible legislators from both political parties including but notlimited to Senators McCain, Vitter and Snowe on the GOP side and Dorgan, Nelson of Florida, Brown of Ohio, Franken and Klobuchar of Minnesota, and even that lovable old Socialist Bernie Sanders have long supported personal importation legislation,only to have it denied by secret deals of the Obama administration with PhRMA,or Poison Pill ‘certification’ requirements.

• ·         We get it that in 2008, then-candidate Obama pledged that he would support personal importation, and then as President Obama, switched his position to prevent PhRMA from mounting a Harry and Louis-type campaign of the type that killed HillaryCare and that the President feared would deal a death-blow to ObamaCare;

• ·         We get it that U.S. prescription medicine prices continue to increase at a rate greater than inflation and are a major driver of the health-care cost crisisthe country faces;

• ·         We get it that Pharma supporters in Congress have tried repeatedly to co-opt legislation regarding intellectual property rights with the insertion of Pharma-driven (and written or directed) sections that would have claimed infringement of copyrights and intellectual property of Pharma, with the unintended consequence of damage to the health and well-being of untold numbers of Americans who wouldlose their access to vital medicines, a factor in the flawed bills that led totheir overwhelming defeat;

• ·         We get it that untold numbers of Americans have safely purchased their medicines viapersonal importation, and their communities and families have benefitted fromtheir enhanced health and well-being;

• ·         We get it that even with a host of governmental programs, millions of Americans are still not able to afford their medicines;

So to our new-found ‘friends’ at CSIP, welcome to the fold.  IF you stick to farrowing out the truly bogus pharmacies, we applaud you.  IF you try to confuse the issue with attacks upon the concept of personal importation, we urge you to be truthful about your real goals.  But don’t think that we don’t get it or that we won't get it..  As I said, we didn’t fall off the turnip truck yesterday.