Tuesday, March 31, 2015

Enough is Enough: Time to refute Pharma's 'claims', and for Congress to Act on Personal Importation of Safe, Affordable Medicines

After working for nearly 15 years on behalf of support of the right of Americans to purchase safe, affordable prescription brand name medicines from licensed registered pharmacies in Tier One countries, I am not usually shocked by the tactics of Pharma and its supporters to discredit the safety and efficacy of personal importation.

But, I did suffer what the old Baptist Preacher once referred to as ‘Righteous Indignation’  when I read a blog in The Hill by Sally C. Pipes with her blog “Drug importation is a dangerous idea that won’t die”

Why?  It  was one of the worst examples I have witnessed of a complete disregard for facts, and insulting the intelligence of the American public.

Her claims about safety of personal importation and the risks to Americans were not supported except by the old canards of Pharma. 

And, the rank misstatements about the costs of medications in this country were ludicrous...she said, believe it or not, prescription drug costs are not major drivers of health care costs nor are they increasing, completely ignoring that they are indeed exceeding the rate of inflation and spiking to costs that threaten to decimate health care systems around the country.

But then I did some googling...and discovered that Ms. Pipes, who is president, CEO and Taube Fellow in Health Care studies at the Pacific Research Insititute is just doesn’t get it, likely the residue of exposure to the outlandish claims of Mayor Guiliani, for whom she served as one of his four health care advisors in his bid for the Republican nomination for president in 2008.  While he will also be remembered as America’s Mayor of his efforts after 9-11, he also had some fatal flaws, including believing personal importation to be a terrorist threat.  While Ms. Pipes does not go that far, her claims of personal importation being a ‘dangerous threat’ to the health and well-being of Americans is up there with Mayor Guiliani’s claims of terrorism.  There is no there there.

With that in mind, I began to look at the Blog as an opportunity for a point-by-point rebuttal of her claims.  The ‘dialogue’ follows, with her comments followed by a response to set the record straight:

·         The Claim:  “A federal judge just struck down a program in Maine allowing state residents to import prescription drugs from foreign countries. The reason: it’s against federal law...”

The facts:  Either a total misreading of the ruling or a blatant misstatement of facts. The ruling had nothing to do with the legality of personal importation.  What the Judge dealt with was the question of Federal Supremacy. She decided that while the state lacked the authority to act, it is clearly within the right and intent of Congress to address legislation to allow personal importation if it chooses to do so. She (the judge) also noted that Congress has acted in such a manner many times with passage of bills in support of personal importation that were not fully implemented because of failure of ‘certification’ actions by the executive branch. Ms. Pipes  also fails to note that existing law allows the importation of medical devices and medicines that are ‘unavailable’ in the US...simply put, a medicine that is unaffordable is unavailable. Significantly, the FDA has selectively allowed 90-day quantities of personally imported medicines for years.

·         The Claim:  “And more immediately, foreign drugs pose a risk to Americans' health...”

The Facts:  A complete falsehood. The judge’s decision did not include such a statement. This is simply the Mantra of Pharma. It also exhibits Ms. Pipes’ long-standing bias of adopting outlandish claims of Pharma.  Virtually all prescription medicines sold in the U.S. are manufactured outside the U.S.  We can all agree that the scourge of bogus websites claiming to be pharmacies and dispensing counterfeit medicines without a prescription form a doctor is a potential health threat. However, there is no record of a single death or health risk to Americans as a result of personally importing their medicines prescribed by their physician and ordered from licensed, registered pharmacies.

·         The Claim:  “For this reason nearly every Congress since the Clinton administration has decided against legalizing drug importation...”

The Facts:  Ms. Pipes would be well-advised to become more conversant or at least be factual about American political history regarding personal importation.  There have been several instances of staunch bi-partisan support of personal importation in Congress, from such Congressional leaders as then-Congressman Rahm Emanuel (D-Chicago) who later became Chief of Staff for President Obama before becoming Mayor of Chicago; Senators Olympia Snowe (R-ME) and Byron Dorgan (D-ND) who brought forth legislation that was approved on preliminary votes only to be rendered ineffective by ‘certification’ requirements upon the Secretary of Health and Human Services that were unprecedented and supported by Pharma interests in Congress.  But, perhaps most significantly, the FDA has, as noted above, espoused a policy of not seeking prosecution of individuals personally importing their medicines.

·         The Claim: “But some in Congress are pushing to open up America's medicine cabinets to foreign drugs. Indeed, Sens. Amy Klobuchar (D-Minn.) and John McCain (R-Ariz.) have repeatedly introduced legislation to allow the importation of drugs. When Congress debates the nation's budget later this month, Klobuchar and McCain could attach a drug-importation amendment. If they succeed, it will come at a huge cost to American patients...”

The Facts:  Ms. Pipes not only misrepresents the Judge’s decision in the Maine suit, but in her next breath, she would deny American elected-officials the right to act in the very manner prescribed by the Judge—i.e., Congressional action. Since her stance is un-defendable she resorts to a vague reference of an undefinable ‘cost’ to Americans.  Actually, more than 55 million Americas today are denied the health benefits of access to safe, affordable prescription medicines simply because of paying the highest prices for prescription drug costs in the industrialized world.  Without an ability to follow a regimen of vital prescribed medicines, they incur real costs detrimental to their financial and health well-being. This will adversely affect their personal health later in life, likely contributing to diseases and conditions that are inherently drivers of increased health care costs that  could have been averted if access to vital medicines had been available previously.  Interestingly, Ms. Pipes and her organization claim to be supportive of personal responsibility and individual freedom in the marketplace.  Is she aware that former Congressman Ron Paul supported personal importation with a bill that said , ‘just do it.’ 

·         The Claim:  “On the face of it, allowing Americans to purchase prescription drugs from abroad is an appealing idea. Thanks to price controls, drugs in my home country of Canada, if they are even available on a formulary, often carry a lower price tag than their American counterparts. In the UK, meanwhile, per capita prescription drug spending is about half what it is in the United States...”

The Facts:  As Senator Berne Sanders said, ‘show me the dead Canadians...’ The comment about if a drug is ‘even available’ on a formulary is pandering by Ms. Pipes to those Americans who don’t truly understand the breadth of the Canadian system and fear that it somehow might be a threat to the U.S.  Ms. Pipes makes an almost painful concession that prescription medicines prices are indeed lower in Canada than the U.S., and the same is true of the U.K.  What she fails to note is that this is true in virtually all the other industrialized Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S., all the while offering prices of as much as 60 to 80 percent less.  And, even for those in the U.S.  who can ‘afford’ their medications, here’s a report on how much they ‘overpay’:  $1,268 for Overpriced Medications
According to Dean Baker, "government granted patent monopolies raise the price of prescription drugs by close to $270 billion a year compared to the free market price." This represents an astonishing annual cost of over $2,000 to an average American family.  OECD figures on pharmaceutical expenditures reveal that Americans spend almost twice the OECD average on drugs, an additional $460 per capita. This translates to $1,268 per household.

·         The Claim:  “While importing prescription drugs might save American patients money in the short-term, it comes with enormous long-term costs. For one, it cuts off the research funding that drug laboratories need to develop the next generation of treatments. According to researchers at Tufts, it takes drug companies roughly $2.5 billion over the course of a decade to bring just one new medicine to market...
·         “...One of the reasons countries like Canada can impose price controls on their drugs is that much of that multi-billion-dollar investment is made back in the American market. A wave of drug importation would make pharmaceutical investment far less attractive, choking off funding for the researchers who work to develop the next generation of treatments for diseases like cancer and Alzheimer's...”

The Facts:  The implication is that Canada is able to charge less because Americans pay more and this is necessary for R&D.  This is the oft-disproven canard of Pharma and is without any basis in fact, especially since U.S.taxpayers subsidize 56 percent of the R&D, which is done at the National Institute of Health (NIH). 

Take a look at the R&D expenditures of Pharma as compared to the ‘marketing’ directly to consumers, which is forbidden in Canada.

  

The drug industry’s claim that R&D costs as much as $250 million for each new drug (including failures) is highly misleading. The first thing pharmaceutical companies say when they answer questions about the retail cost of drugs is that prescription drugs cost a lot of money to get approved by the FDA. That stems from the millions of dollars that get spent developing the drugs for which they get a virtual monopoly.

That is why Pharma spokespersons can make such outrageous claims such as “The drug companies have to put a price on a medicine that reflects the cost of developing them,”  as John Castellani, the CEO of PhRMA told 60 Minutes. Castellani blames insurance companies for making drugs “artificially expensive” for patients.

In fact, the more disturbing truth is that companies charge what they want in the U.S., and it’s what many have described as “a profiteering paradise for them.”

PhRMA, the industry lobbying group, released a 2013 report showing that drug companies spent an estimated $48.5 billion on R&D in 2012. The most current figures they have (from the early 2000′s) show the cost of developing one drug is about $1.2 billion.  However, University of Medicine and Dentistry of New Jersey Health professor and policy expert Donald W. Light challenged the notion that high drug prices are simply the cost of doing business. He said the actual cost is less than $60 million once all the padding is taken off since the estimate is based on only the most expensive drugs with extensive clinical trials.

We agree with the observation of industry observers that, as noted as long ago as a 2001 report of Public Citizen, it defies logic that R&D investments are highly risky if the industry is consistently so profitable and returns on investments are so high.

Drug industry R&D is made less risky by the fact that only about 22 percent of the new drugs brought to market in the last two decades were innovative drugs that represented important therapeutic gains over existing drugs. Most were "me-too" drugs, which often replicate existing successful drugs.

·         The Claim:  “This is especially true when you consider that prescription drugs aren't a major driver of rising health expenditures. Between 2008 and 2012, prescription drugs accounted for a mere 5 percent of the growth in U.S. health spending. Today, retail prescription drugs account for only about 10 percent of overall U.S. health spending -- a statistic that isn't expected to change in the next decade...”
·         The Claim:  “None of these concerns has dissuaded Klobuchar, who, together with McCain, has led the fight to legalize drug importation. Twice last year, the two lawmakers introduced legislation to let foreign medicines flow freely into the country...With this latest attempt, Klobuchar and her allies may try to win over Senate Republicans by portraying drug importation as a free-trade issue. But importing price controls from foreign countries -- at the expense of both medical innovation and patient safety -- bears little resemblance to free trade...”
The Facts:  Saving the best for last.  One of my early experiences with the way Pharma works is when I was able to arrange a luncheon for then-Governor Tim Pawlenty (R-MN) after the Pfizer board meeting in St. Louis with Seniors who personally imported their medicines .  The Governor was livid when he came into the luncheon, primarily over comments by the then-Chairman of Pfizer Hank McKinnell in response to the Governor’s call for an election-year ‘Prairie Fire’ to support personal impoartation.  Chairman McKinnell said that personal importation really was like a Prairie Fire and that Pfizer was used to such things happening about every three or four years, before they burn out as an issue.  But, most surprisingly, McKinnell suggest that personal importation was really—are you ready Ms. Pipes—a free trade issue. The point is that just as it charges what the traffic will bear, Pharma also says what pleases it as any given time.

So it is not surprising that Ms. Pipes should dust off the old tired defenses as she recites the Pharma litany.  She mistakenly believes, as did the Pfizer Chairman, that the American people are not able to adequately make very real personal health decisions based on  intelligent considerations...and that the Prairie Fire will go out again.  It is time for Congress to prove her and others wrong.

Wednesday, March 11, 2015

Why High Drug Prices require an RxBill of Rights for Americans (Part One)

Why High Drug Prices require an RxBill of Rights for Americans (Part One)
Publisher’s note:  This is the first of a three part series on why Americans need an RxBill of Rights that will guarantee their access to safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One countries whose standards of Safety and Efficacy meet or exceed those of the US.  In Part Two, we will examine the abuse of the public policy process by Pharma to exercise undue influence that makes the US a safe haven for predatory pricing practices of Pharma, and what the potential public health care consequences are of that influence.  In Part Three, we will explore examples of the pricing policies of Pharma, including the concerns over the costs of ‘specialty’ medicines and the spike in Generics.  We will also present our case for an RxBill of Rights for Americans based on a role for the American public as a part of the stakeholder community with a specific interest in the costs of medicines, and having a role in the deliberative process of legislation, policy making and implementation of health care policy as it involves the benefit, savings and overall well-being, happiness and health of American citizens.


Then, imagine that when people who are supposed to represent your interests in an elective body turn instead to the very entities that are offered a ‘safe haven’in that country for those prices as ‘stakeholders’ to ‘invitation only’ opportunities to shape that country’s public health policy.

But wait!  Generic drugs can offer relief for the battered pocketbooks of people of this country, supposedly offering medicines at a fraction of the cost of the more expensive brand-name medicines...can't they?

Unfortunately, no...instead, these supposedly less-expensive alternatives are recognized as opportunities for immense profits merely by raising the prices by as much as nearly 1000 percent. 

And, imagine that when miraculous cures are found for diseases, that instead of a Jonas Salk model in which the founder of the vaccine to eliminate polio said that the rights to the cure were those of people around the world, the drug company that develops the medicine charges $1,000 a pill, putting the total cost to each individual (in this instance, Hepatitis C) a staggering $100,000, allowing the company making it to register 2nd Quarter profits of $3.67 billion.

Finally, imagine that this fictitious country had the capability to provide lower drug costs for all its citizens by allowing them to personally import valid, brand-name prescription medicines, from licensed registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of those in the U.S., and could offer those medicines at prices at as much as 60 to 80 percent less that the overly-expensive medicines currently protected.

Then imagine that those who oppose lower medicine prices use their vast funds, political contributions, front groups to deter the rights of the citizens of that country to purchase these medicines.

Unfortunately,  you don't have to imagine.  The country is very real.  It is the United States.

But there is a solution.  It rests with the United States Congress. Ironically,  a recent decision by a District Court Judge in Maine which opponents of personal importation hailed, might offer a road map to bold actions that could lead to lower prescription medicine prices.
While Pharma may believe that it has gained a victory in the ruling by Judge Nancy Torresen, Chief Judge of the United States District Court for the District of Maine, determining the right of the state of Maine to allow its citizens to personally import their medicines, it may want to pause before taking a victory lap.

Yes, the Judge’s decision did set aside the Maine law, passed by the state’s Legislature allowing Maine citizens to purchase brand-name medications from licensed, registered pharmacies based in Canada, the United Kingdom, Australia and New Zealand. 

The Legislature passed the law after the then-Attorney General, acting at the bequest of the state’s Pharmacy Board and the Maine Pharmacy Association, banned the sale of such pharmaceuticals because the pharmacies dispensing the medicines were not registered with the Main Pharmacy Board.

The Attorney General’s action occurred even though Maine Citizens utilizing the state’s proximity to Canada, have travelled across the border to purchase their medications for years, while others were purchasing their medicines through plans offered by businesses acting to make such safe, affordable prescriptions available to their employees through employee benefit plans.


The opponents to personal importation immediately initiated legal action based upon the contention of ‘Federal Supremacy’.  The issue for the courts was to determine federal law preempts state law when it comes to prescription drug imports.  She decided that it does.

Therein lies the basis of what has been a debate about the American process since our country’s founding—state rights and authority vs. that of the Federal Government over state actions.

Undoubtedly, the interest of PhRMA, acting on behalf of its members—and affiliated front groups—was based on fear that if the Maine legislation were to be upheld by the District Court, it would set the stage for other states to recognize what the American public has known for more than 15 years—that personal importation of safe, affordable brand-name medicines from licensed, registered pharmacies in Tier One Countries whose standards of safety or efficacy meet or exceed those of the United States has increasingly over the history of personal importation become the only safe, affordable counter to the ‘Safe Haven” provided to Pharma  in the US for the highest prescription drug prices in the Industrial World.


He mentioned only in passing that PhRMA itself had been dismissed from the suit by Judge Torresen as having no standing because there was no evidence of ‘harm’ that might have been done to PhRMA. 

He continued his disingenuous stance by noting that: ““Last night, a federal judge in Maine agreed with our position. In short, the Court invalidated the importation law in Maine by ruling that, along with specific authority vested in the Food and Drug Administration (FDA) to regulate drug importation, the ‘FDCA’s drug approval, labeling, and packaging provisions demonstrate a clear Congressional intent to tightly control prescription drug importation, - See more at:
http://www.phrma.org/media-releases/phrma-statement-on-court-ruling-on-maine-importation-law#sthash.Aqsyn1Rh.dpuf

The fact is that the FDCA reflects only the judge’s opinion that Congress indeed does have the jurisdiction to pass laws regarding the status of personal importation.  There is no reference to denying Americans access to their right to personally import medicines if Congress deems to act to allowing such access.

The ruling points out that the FDA itself has, as a matter of practice, allowed personal importation of prescription medicines as expressed in public statements, saying that it does not criminally prosecute individuals who personally imported up to 90-day supplies of their medicines.

Proponents of personal importation cite this as a de facto acceptance of personal importation.

The ruling also points out that Congress itself has passed legislation allowing personal importation with a caveat of ‘certification’ of safety by the Secretary of Health and Human Services. 

Unfortunately, this caveat has not been accompanied by Congress compelling the HHS Secretary to take steps to implement such certification, allowing instead, the option for the Secretary to exercise his or her own discretion as to whether to undertake such certification or even to offer Congress a reason for failure to act.

All of this masks the fact that brand-name medicines personally imported by American citizens from Tier One Countries are both valid and authentic medicines that of equivalent quality, safety and efficacy as their the same medicines sold in the US, at prices as much as 60 percent higher than the same medicine personally imported from a Tier One Country.

Equally, important, Mr. Murphy’s words may come back to haunt him if legislation in the form of S.122 – The Safe and Affordable Drugs from Canada Act of 2015 introduced by long-time allies of personal importation, Senators Amy Klobuchar (D-MN) and John McCain (R-AZ).

The bi-partisan legislation would allow the personal importation of brand-name medicines from Canadian sources, but, most importantly,  would require the HHS Secretary to undertake steps to implement the provisions of the bill, rather than making it an option for the Secretary.

It will be interesting to see if Mr. Murphy is as steadfast in his stand of support for Congress clear intent to control personal importation or will he join a fellow PhRMA attorney  Sarah A. Spurgeon, Assistant General Counsel of PhRMA,   who urges that FDA take action against individuals importing drugs in violation of the law, including use of its new destruction authority once FDA has finalized this proposed rule (for Section 708).”

This is a blatant appeal for the FDA to criminalize personal importation with actions against individuals for whom personal importation is a lifeline to vital medicines. 

An examination of the reactions of others who were party to the ruling indicate that they will attempt to distort in a way that Judge Torresen never intended:

·        Kenneth McCall of the Maine Pharmacy Association says, as a pharmacist, he sees first hand that cost is an issue for consumers - it's just that Maine's drug importation law is not the way to solve it.  "I think we can continue to look for better options," he says.
The obvious response is for McCall to deal first hand with an explanation of what he believes ‘better options’ might be.  We contend that Judge Torresen has laid it out—Congressional action such as S.122 setting a standard that ensures that the FDA finally fulfills the intent of Congress.

·        The problem, says Curtis Picard of the Retail Association of Maine, one of the plaintiffs in the case, is that it violated federal law. "The contention of our lawsuit was that the federal government regulates what can and cannot come into the United States," Picard says. "There's a lot of reasons for that...”
Really, Mr. Picard.  Other than the question of Federal supremacy, cite where the Judge presented any other reasons.

Interestingly, at the time of this post of this blog, PhRMA front groups such as The Center for Safe Online Pharmacies and the Alliance for Safe Online Pharmacies have not made a statement about the judgment.

Where does all this go?  The case might be appealed.  There is no guarantee it will be upheld.  Congress might pick up the cue from Judge Torresen and say, ‘Yes, we do have authority, and now, by God, we are doing to exercise it to (a) ensure that the FDA, HHS and unelected bureaucrats finally enact what we have said in many votes in the past, namely that personal importation of brand name medicines from Tier One Countries is safe—and affordable. “

It is time to call out the harmful effects of the undue influence of Pharma upon public health policy.  It is time for an RxBill of Rights on behalf of Americans.