Prescription drug personal importation bill fails in Senate. 'Do no Harm' to personal importation should be goal of policy-makers

Watching the ‘debate’ regarding the amendment by Senator John McCain (R-AZ) in support of his amendment to the Food and Drug Administration funding bill to establish astructure for personal importation of prescription medicines by individuals,one had to have a feeling of de javu.

There were so many  familiar faces.  Senator  McCain  showing his irritation and frustration at the continued success of Pharma in derailing any importation legislation…Senator Charles Grassley (R-IA) once again exhibiting the Midwestern Common Sense that has made him a favorite with Iowa voters…Senator Olympia Snowe (R-ME) in a last hurrah before retiring after this term, showing the passion and leadership that has made her name synonymous with personal importation through the bills that bore her and former Senator Byron Dorgan’s(D-ND) names. 

She even used the Lipitor example of the former Senator Dorgan and one could only wonder if Senator Dorgan, who retired from the Senate after his last valiant effort topass legislation favorable to personal importation—a failure which he laid at the doorstep of the White House, accusing the Obama Administration ofdeal-making with Pharma--would appear on the Floor and lend her his favorite prop, a bottle of Lipitor, the most profitable medicine ever developed. 

At the same time, one had to wonder why Senator Snowe used the Lipitor example since the drug no longer has its patent protection, and a flood of generics is expected to erode the market Lipitor enjoyed when it had such protection.

There were many of the same Pharma supporters of past debates, who pooh-poohed Senator McCain’s charges about Pharma influence, which is so obvious that to deny it is and of itself a self-proving action. 

But while the amendment went down in flames with 43 yeas, 54 nays (60 votes needed toadoption), there were other reasons that it failed, none of which has anything to do with the merits, benefits and record of personal importation.

Not the least of these was an old problem continues to be troublesome for  importation legislation and is an indication that since there likely will be no form of legislation passed, the goal should be to protect the right to personal importation.  Although the amendment has passed in the Senate many times, it has always had a challenge in even being called up for a vote.

Former Senate Majority Leader Bill Frist (R-TN), who has since returned to private medical practice, reneged on his commitment to bring the proposal up for a vote during the administration of George W. Bush.  This led to a running discussion throughout  that session of Congress and succeeding sessions of what strategy would be employed to identify a ‘vehicle’ to which to attach the legislation.

The problems continued with the election of President Barrack Obama. 

Supporters all believed Candidate Obama to be a proponent of personal importation, until an aide, Dora Hughes, said in September 2008 that Candidate Obama was not as strong a supporter of personal importation as had been presumed. 

Still, while at a hearing in St. Louis by Senator Claire McCaskill, when I asked the Senator   about the Obama position, she assured me that it would be the first bill he signed into law.

Alas, we were soon to discover when President Obama made a closed-door, back-room deal with Pharma to not support personal importation in return for a Pharma guarantee of not doing a ‘Harry and Louise-type attack’  upon the President’s healthcare proposal, that,alas, Ms. Hughes’  insights were better than Senator McCaskill’s.  And,  as noted earlier, Senator Dorgan  bemoaned the lack of leadership from the Obama Administration when his final effort also fell short of the 60-vote threshold,citing the deals made by Pharma with the Administration.

The simple truth:  The President early on determined that Healthcare Legislation was to be his legacy.  The economy and joblessness were set aside, as was prescription medicine importation .

Part of the closed-door negotiations including blocking personal importation was to strike a deal that supposedly was to reduce the costs of medicines for Seniors in the Doughnut Hole by $80 billion (but which because of the delay of enacting the cuts, and prescription price increases, has been one of the best investments Pharma ever made—even more lucrative than the multi-million investment in former Representative Billy Tauzin (D-LA) who engineered the passage of Part D,  and then resigned his post to immediatelybecame head of PhRMA, the industry’s trade association).

If anyone wonders why Senator McCain was so upset during the most recent claims by Pharma's Senators that healthcare policy is not/has not/and will not be influenced by Pharma—which Senator McCain described as the very type of thing that has eroded public confidence in Congres-- may I suggest it was not ‘anger’ or temper, it was righteous indignation.

Still, the amendment he offered and 41 other Senators supported was defined by situations that reflected the same, albeit , valid arguments made since Seniors were the first Americans to turn to personal importation of prescription medicines at the turn of the Century 12 years ago via bus trips to Canada to order their medicines at tremendous savings of as much as 60 percent.

Their actions were to give rise to a vigorous new industry—the establishment of certified, licensed, and registered pharmacies dispensing medications via the Internet, thereby allowing more than just the Americans located on the Northern US Border to have access to safe, affordable brand-name medicines at tremendous savings.

It also spurred many local groups, governments and others individual Americans to realize that they could attain fiscal relief through personal importation , all the while providing the  health benefits of  access to safe, affordable brand-name medicines.

Lower costs…improved health…fiscal savings…safety…a competitive alternative to the highest prescription medicine prices in the world…those are the drivers that make personal importation still the most viable option available to lowering US prescription medicine prices.

Personal importation validates that Americans can use their Common Sense in exercising their right and ability to make responsible healthcare decisions.  That native Common Sense is absent from the US Congress that has failed in developing solutions to the challenge of high prescription medicine prices that before the widespread use of personal importation forced millionsof citizens to do either without their vital medicines or without other  life-supporting services such as food andshelter.

And therein, I submit, lies the root of the ‘solution’ to the challenge of presentation and support of any legislation that might be presented in the future in support of personal importation—namely, illustrating how personal importation reflects the inherent Common Sense of the American people, similar to Rep. Ron Paul's (R-TX) proposal (HR 147) to basically, 'just do it,' which we have supported for sometime.

The McCain amendment was self-defeating with its emphasis upon restrictions of sourcing that limited personal importation to only medicines from Canadian internet-based pharmacies because the language had ambiguities that would have made the amendment ineffective.  Example: the medicines would by my reading have to be dispensed specifically by a Canadian Internet pharmacy,  restricting the ability to have medicines dispensed from licensed, registered pharmacies in other countries whose standards of oversight and efficacy meet or exceed  those of pharmacies in Canada or the U.S.

The legislation also called for the Secretary of Health and Human Services to ‘certify’ the involved pharmacies, although they have been approved by the appropriate provincial licensing authority in Canada.  In a touch of irony, previous forms of personal importation legislation that have passed the Senate have been turned aside by opponents of personal importation by the introduction of ‘poison pill’ amendments requiring ‘certification’ by the Secretary of Health and Human Services that any imported medicine is safe.

 It’s a ridiculous position, one that was first introduced at the same time that Ford F150’s were crashing and burning, causing me to suggest to then-Senator James Talent’s (R-MO) staff, that the ‘certification’ of the safety of ALL vehicles, tires, engines, etc.,  should be demanded of  the Secretary of Transportation, requiring that he or she ‘certify’ that there would be no recalls nor safety problems with the Ford vehicles at that time, or other situations that could affect the safety of a vehicle.

What will be next? 

Perhaps the Online Pharmacy Safety Act, introduced by Senator Diane Feinstein (D-CA) and Senator Jeff Sessions (R-AL)  that would empower the Secretary of HHS to utilize the VIPPS Certification Program of the NationalAssociation of Pharmacy Boards to ‘certify’ online pharmacies in the US, an authority it denies certification services such as PharmacyChecker.com andPharmacy Accreditation Services, designed specifically to provide oversight services for Internet pharmacies.

Senator Snowe described the McCain Amendment as a ‘first step.’  Actually, the first step was taken years ago by millions of Seniors  , followed by untold numbers of other Americans for whom personal importation of brand-name medicines has provided a lifeline to vital medicines that have contributed to their health, finances, and well-being.

By continuing the comparisons of price differences alone, without a greater emphasis upon the beneficial contribution and proven record of personal importation to providing fair and equitable pricing for vital medicines, and improved health, the proponents of personal importation, of whom I am one, continue to allow opponents to trot out the same old tired saws about rogue pharmacies, the claimed 'dangers ' of the Internet from even legitimate safe pharmacies, and the claimed negative impact upon R&D of new medicines.

Even after  Pharma’s stunning defeat in the Stop Online Pharmacy Act,  the latest vote is indicative that Senator McCain’s lament about the influence of Pharma inside the Beltway is ‘on spot.'

It is time for proponents of personal importation to shape their message and quit dribbling the basketball at Pharma’s 50-yard line and come forth with the proven merits and benefits already made possible by personal importation.   By developing such a message of what the past and future benefits will be, not merely for the purpose of passing legislation but to ensure Congress acts to block Pharma's continuing effort to scare the American people in such a way as to keep them using their Common Sense to continue exercising their right--and capability--to make responsible healthcare decisions, and to distinguish facts from Pharma-driven-fiction--the continued beneficial contribution of personal importation shall be ensured.

Stop Online Piracy Act endangers health of millions

The law of unintended consequences is a warning that an intervention in a complex system tends to create unanticipated and often undesirable outcomes

The Stop Online Piracy Act (SOPA) claimed by its sponsors to be the answer to protecting the intellectual property of Americans—an admirable goal—is the latest example that will without doubt lead to unintended consequences that will affect the health and well-being of millions of Americans by denying them access to safe, affordable medicines from reputable pharmacies in countries outside the U.S. .

Furthermore, the proposed legislation will not meet its goals, because it will create an unworkable and vague enforcement trigger that does not rely upon a system of law and courts, but instead that allows the Justice Department to cede to private entities the right to initiate action against individuals or websites, with such action carrying with it an assumption of guilt of the party being charged.

I shall leave it to Constitutional experts to illustrate the questionable constitutionality of SOPA. However, I believe it almost certainly will be used as a weapon against free speech and differences of opinion by some who will claim that a promotion of a product or service t violates the intellectual property right of the entity making the charge.

This includes, but is not limited to, the Pharmaceutical industry (Pharma)—an industry whose pricing practices have imposed the highest-cost drugs in the World upon Americans.

This has led to Americans using their common sense and exercising their right—and ability—to make personal health care decisions for more than a decade to purchase safe, affordable medicines. These are the very same ones that would cost at much as 60 percent more,if purchased in the U.S., rather than from reputable sources in other countries, countries whose standards of safety and efficacy meet or exceed those of the United States.

The passage of SOPA would endanger that capability by allowing Pharma to initiate actions against websites or individuals that Pharma could claim was promoting infringement upon its intellectual property rights.

I have mentioned unexpected consequences, Unfortunately, the stage for those consequences has been set by recognized consequences of the pricing of medicines in the U.S.

· As the skyrocketing costs of brand name drugs leave millions of Americans skipping doses or abandoning their prescriptions, investors representing 14 faith and health care organizations are petitioning the nation's top pharmaceutical companies to re-examine pricing for commonly used drugs like Lipitor, Plavix and Celebrex in an effort to make them more affordable;

· Cost of heart drugs makes patients skip pills, putting themselves at risk (Mayo Clinic);

· U.S. prescription drug spending will grow 93% during 2008-2018, exceeding all major categories of health expenditures (Centers for Medicare and Medicaid Services);

· Americans failing to fill prescriptions or not taking their medicines as prescribed because of costs of medicines (Consumer Reports);

· Bi-partisan identification of the problem of healthcare costs in resolving our fiscal crisis (Senator Richard Durbin (D-IL), former Senator John Danforth (R-MO);

· Reports of Seniors falling Into Doughnut Hole buying fewer drugs (Kaiser Family Foundation);

· As many as one in ten elderly people in the US, registered with Medicare, not have access to their prescribed medication because it is too expensive (Dr. Larissa Nekhlyudov and colleagues from Harvard Medical School);

It is staggering to consider the negative impact—an unexpected consequence--that will occur as millions of Americans who rely upon personal importation of their safe and affordable medicines find that they must now be without their vital medicines because of legislation supposedly designed to protect American intellectual propert without any consideration of its impact because of the proposal’s vague language.

Fortunately, there is also recognition of the beneficial role of personal importation of vital medicines in protecting the health of Americans:

· Recognition of the ‘safety valve’ function of personal importation in preventing prescription medicine prices from going even higher “Basically, what’s going on with Canada is a little bit of leakage, It’s a release valve so that American consumers don’t get more upset with the prices’’ ( Arthur A. Daemmrich, assistant professor of business administration at Harvard Business School);

· Formation of a Congressional Caucus by Representatives Joanne Emerson (R-MO) and Peter Welch (D-VT) to work to lower prescription drug prices (Representative Emerson is a long-time supporter of personal importation of prescription medicines);

· Adoption of a new policy by the FDA facilitating importation of ingredients for pharmaceutical manufacture in the U.S. to address drug shortages in this country via reciprocal agreements with regulatory agencies in other countries, validating a process of reciprocity long advocated by supporters of personal importation;

· Numerous private and government support systems exist to help ease the cost for America's poor, but there are still millions of patients who are uninsured, and many who can't find cheap medicines in the U.S. look abroad To avoid high prices at home, U.S. patients have trekked to Canada for decades to buy their medicines… pharma companies and myriad industry-funded groups have scared Americans into believing that drugs from overseas pharmacies are inherently dangerous (American Enterprise Institiute);

· Introduction of legislation by Senators Al Franken (D-MN) and Amy Klobuchar (D-MN) supporting personal importation to relieve the growing problem of shortages of medicines in the U.S..

So it is now up to the House of Representatives to act, aware that if they sow the wind of SOPA, they will reap the whirlwind of endangering the health of millions of Americans who rely upon personal importation of their prescriptions medicines.